Abstral Sublingual Tablet

Name: Abstral Sublingual Tablet

Abstral Sublingual Tablet Dosage and Administration

Important Dosage and Administration Information

  • Healthcare professionals who prescribe ABSTRAL on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of ABSTRAL [see Warnings and Precautions (5.7)].
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
  • It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.
  • Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.6)].
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with ABSTRAL; adjust the dosage accordingly [see Warnings and Precautions (5.1)].
  • Instruct patients and caregivers to take steps to store ABSTRAL securely and to properly dispose of unused ABSTRAL as soon as no longer needed [see Warnings and Precautions (5.2, 5.6), Patient Counseling Information (17)].
  • ABSTRAL is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than ACTIQ (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) [see Warnings and Precautions (5.5)].
  • ABSTRAL is NOT a generic version of any other oral transmucosal fentanyl product.

Initial Dosage

Initiate treatment with ABSTRAL for all patients with a single initial dose of 100 mcg. The initial dose of ABSTRAL is always 100 mcg, with the only exception being patients already using ACTIQ.

If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose.

If adequate analgesia is not obtained after a single dose of ABSTRAL, the patient may use a second ABSTRAL dose (after 30 minutes) as directed by their healthcare provider. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain [see Titration and Maintenances of Therapy (2.3)].

Patients must wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL.

Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other products containing fentanyl to ABSTRAL must start with the 100 mcg dose (except patients switching from ACTIQ).

ABSTRAL is not equivalent on a mcg per mcg basis with all other fentanyl products. Therefore, do not switch patients on a mcg per mcg basis from any other fentanyl products. ABSTRAL is NOT a generic version of any other fentanyl product.

Converting to ABSTRAL from ACTIQ

  1. For patients being converted from ACTIQ, prescribers must use the Initial Dosing Recommendations for Patients on ACTIQ. See Table 1 for initial dosing recommendations. Patients must be instructed to stop the use of ACTIQ and dispose of any remaining units. Table 1: Initial Dosing Recommendations for Patients on ACTIQ
    Current ACTIQ Dose (mcg) Initial ABSTRAL Dose (mcg)
    200 100
    400 200
    600 200
    800 200
    1200 200
    1600 400
  2. For patients converting from ACTIQ doses of 200 mcg and 400 mcg, initiate titration with 100 mcg and 200 mcg of ABSTRAL, respectively and proceed using multiples of this strength.
  3. For patients converting from ACTIQ doses of 600 and 800 mcg, initiate titration with 200 mcg of ABSTRAL and proceed using multiples of this strength.
  4. For patients converting from ACTIQ doses of 1200 and 1600 mcg, initiate titration with 200 mcg and 400 mcg of ABSTRAL, respectively and proceed using multiples of this strength.

Titration and Maintenance of Therapy

Titration

The objective of dose titration is to identify an effective and tolerable maintenance dose. From an initial dose, closely follow patients and change the dosage strength until the patient reaches a dose that provides adequate analgesia using a single ABSTRAL dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of ABSTRAL over several episodes of breakthrough cancer pain and review their experience with their healthcare providers to determine if a dosage adjustment is warranted for management of breakthrough cancer pain episodes. The effective and tolerable dose of ABSTRAL will be determined by dose titration in individual patients.

If adequate analgesia was not obtained with the first 100 mcg dose, continue dose escalation in a stepwise manner over consecutive breakthrough episodes until adequate analgesia with tolerable side effects is achieved. Increase the dose by 100 mcg multiples up to 400 mcg as needed. If adequate analgesia is not obtained with a 400 mcg dose, the next titration step is 600 mcg. If adequate analgesia is not obtained with a 600 mcg dose, the next titration step is 800 mcg. During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose. Instruct patients not to use more than 4 tablets at one time. If adequate analgesia is not obtained 30 minutes after the use of ABSTRAL, the patient may repeat the same dose of ABSTRAL. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain. Rescue medication, as directed by the health care provider, can be used if adequate analgesia is not achieved after use of ABSTRAL.

The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies in patients.

In order to minimize the risk of ABSTRAL-related adverse reactions and to identify the appropriate dose, it is imperative that patients be supervised closely by health professionals during the titration process.

Maintenance Therapy

Once titrated to an effective dose, instruct patients to use only one ABSTRAL tablet of the appropriate strength per dose. Maintain patients on this dose.

If adequate analgesia is not obtained after initial dose of ABSTRAL, the patient may use a second ABSTRAL dose (after 30 minutes), as directed by their healthcare provider. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain.

Patients must wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL.

Dose Re-Adjustment

If the response (analgesia or adverse reactions) to the titrated ABSTRAL dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the ABSTRAL dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of breakthrough pain and opioid-related adverse reactions.

If more than four episodes of breakthrough pain are experienced per day, re-evaluate the dose of the long- acting opioid used for persistent underlying cancer pain. If the long-acting opioid or dose of long-acting opioid is changed, re-evaluate and re-titrate the ABSTRAL dose, as necessary, to ensure the patient is on an appropriate dose.

Limit the use of ABSTRAL to treat four or fewer episodes of breakthrough pain per day.

It is imperative that any dose re-titration is monitored carefully by a healthcare professional.

Administration of ABSTRAL

Instruct patients to place ABSTRAL tablets on the floor of the mouth, directly under the tongue, immediately after removal from the blister unit and not to chew, suck, or swallow ABSTRAL tablets. Allow ABSTRAL tablets to completely dissolve in the sublingual cavity. Advise patients not to eat or drink anything until the tablet is completely dissolved.

In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking

ABSTRAL.

Discontinuation of ABSTRAL

For patients no longer requiring opioid therapy, consider discontinuing ABSTRAL, along with a gradual downward titration of other opioids to minimize possible withdrawal effects.

In patients who continue to take their chronic opioid therapy for persistent pain, but no longer require treatment for breakthrough pain, ABSTRAL therapy can usually be discontinued immediately.

Disposal of ABSTRAL

Patients and their household members must be advised to dispose of any tablets remaining from a prescription as soon as they are no longer needed. Instructions are included in Patient Counseling Information (17) and in the Medication Guide.

To dispose of any unused ABSTRAL tablets, remove them from the blister cards and flush them down the toilet. Do not dispose of the ABSTRAL blister cards or cartons down the toilet.

If additional assistance is required, call 1-888-227-8725.

Drug Interactions

Table 4 includes clinically significant drug interactions with ABSTRAL.

Table 4: Clinically Significant Drug Interactions with ABSTRAL
Inhibitors of CYP3A4
Clinical Impact: The concomitant use of ABSTRAL and CYP3A4 inhibitors can increase the plasma concentration of fentanyl resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of ABSTRAL is achieved [see Warnings and Precautions (5.3)].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who have developed physical dependence to fentanyl.
Intervention: If concomitant use is necessary, consider dosage reduction of ABSTRAL until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the ABSTRAL dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice
CYP3A4 Inducers
Clinical Impact: The concomitant use of ABSTRAL with CYP3A4 inducers can decrease the plasma concentrations of fentanyl [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of withdrawal syndrome in patients who have developed physical dependence to fentanyl [see Warnings and Precautions (5.6)].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the fentanyl plasma concentration will increase [see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
Intervention: If concomitant use is necessary, consider increasing the ABSTRAL dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider ABSTRAL dosage reduction and monitor for signs of respiratory depression.
Examples: rifampin, carbamazepine, phenytoin
Benzodiazepines and other Central Nervous System (CNS) Depressants
Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.4)].
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol
Serotonergic Drugs
Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions 5.10].
Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ABSTRAL if serotonin syndrome is suspected.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue)
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions (5.10)] or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.1)].
Intervention: The use of ABSTRAL is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
Examples: phenelzine, tranylcypromine, linezolid
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Clinical Impact: May reduce the analgesic effect of ABSTRAL and/or precipitate withdrawal symptoms.
Intervention: Avoid concomitant use.
Examples: butorphanol, nalbuphine, pentazocine, buprenorphine
Muscle Relaxants
Clinical Impact: Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected, and decrease the dosage of ABSTRAL and/or the muscle relaxant, as necessary.
Diuretics
Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure, and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when ABSTRAL is used concomitantly with anticholinergic drugs.

Use in specific populations

Pregnancy - Category C

There are no adequate and well-controlled studies in pregnant women.

Risk Summary:

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with ABSTRAL in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. When administered during gestation through lactation, fentanyl administration to pregnant rats resulted in reduced pup survival at doses within the range of the human recommended dosing. No evidence of malformations were noted in animal studies completed to date [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy can occur regardless of the heath of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset of neonatal withdrawal symptoms usually occurs in the first days after birth. The duration and severity of neonatal opioid withdrawal syndrome may vary. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.8)].

Labor or Delivery

Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. ABSTRAL is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including ABSTRAL, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Data

Human Data

In women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers.

Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl.

Animal Data

Fentanyl has been shown to be embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.4 times the 800 mcg dose of ABSTRAL on a mg/m2 basis) and 160 mcg/kg subcutaneously (2 times the 800 mcg dose of ABSTRAL based on a mg/m2 basis). There was no evidence of teratogenicity reported.

No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2 weeks prior to breeding and throughout pregnancy. The high dose was approximately 6 times the human dose of 800 mcg ABSTRAL per pain episode on a mg/m2 basis and produced mean steady-state plasma levels that are 6 times higher than the mean Cmax observed following administration of 800 mcg dose of ABSTRAL in humans.

Lactation

Risk Summary

Fentanyl is present in breast milk. One published lactation study reports a relative infant dose of fentanyl of 0.024%. However, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production.

Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with ABSTRAL.

Clinical Considerations

Monitor infants exposed to ABSTRAL through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Females and Males of Reproductive Potential

Infertility

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.1), Clinical Pharmacology (12.2), Nonclinical Toxicology (13.1)].

Pediatric Use

The safety and efficacy of ABSTRAL have not been established in patients below 18 years of age.

Geriatric Use

Of the 270 opioid tolerant patients with breakthrough cancer pain in the Phase 3 clinical studies of ABSTRAL, 58 (21%) were 65 years of age and older. There was no difference in the median titrated dose in patients aged 65 years and older compared to those <65 years. No clinically meaningful difference was noted in the safety profile of the group 65 years of age and older, as compared to younger patients in ABSTRAL clinical trials.

Elderly patients have been shown to be more sensitive to the effects of fentanyl when it is administered intravenously, compared with the younger adult population. Therefore, exercise caution when individually titrating ABSTRAL in elderly patients to provide adequate efficacy while minimizing risk.

Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant, or when opioids were co- administered with other agents that depress respiration. Titrate the dosage of ABSTRAL slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.9)].

Fentanyl is known to be substantially excreted by the kidneys, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Patients with Renal and Hepatic Impairment

Insufficient information exists to make recommendations regarding the use of ABSTRAL in patients with impaired renal or hepatic function. Fentanyl is metabolized primarily via human cytochrome P450 3A4 isoenzyme system, and the inactive metabolite is mostly eliminated in urine. If the drug is used in these patients, use the drug with caution because of the reduced hepatic metabolism and renal excretion capacity in such patients.

Sex

Both male and female opioid-tolerant cancer patients were studied for the treatment of breakthrough cancer pain. No clinically relevant sex differences were noted either in efficacy or in observed adverse reactions.

Abstral Sublingual Tablet Description

ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, an opioid agonist, intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths (100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg), distinguishable by the shape of the tablet and by debossing on the tablet surface.

Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula:

All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 mcg strength tablet contains 100 mcg of fentanyl free base.

Inactive Ingredients: Croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate the carcinogenic potential of fentanyl have not been performed.

Mutagenesis

Fentanyl citrate was not mutagenic in the in vitro Ames reverse mutation assay in S. typhimurium or E. coli, or the mouse lymphoma mutagenesis assay, and was not clastogenic in the in vivo mouse micronucleus assay.

Impairment of Fertility

Fentanyl has been shown to impair fertility in rats at doses of 30 mcg/kg intravenously and 160 mcg/kg subcutaneously. Conversion to the human equivalent doses indicates that this is within the range of the human recommended dosing for ABSTRAL.

Patient Counseling Information

Advise the patient to read FDA-approved patient labeling (Medication Guide).

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting ABSTRAL or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.1)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Increased Risk of Overdose and Death in Children Due to Accidental Ingestion

  • Healthcare providers and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time, or visiting, basis) and counsel them regarding the dangers to children from inadvertent exposure [see Warnings and Precautions (5.2)].
  • Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)].
  • Instruct patients to take steps to store ABSTRAL securely and to dispose of unused ABSTRAL by removing them from the blister cards and flushing them down the toilet [see Disposal of Unopened ABSTRAL Blister Packages When No Longer Needed].
  • Instruct patients and caregivers to keep both used and unused ABSTRAL out of the reach of children [see Warnings and Precautions (5.2)].

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if ABSTRAL is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.4), Drug Interactions (7)].

Addiction, Abuse, and Misuse

Inform patients that the use of ABSTRAL, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.6)]. Instruct patients not to share ABSTRAL with others and to take steps to protect ABSTRAL from theft or misuse.

Transmucosal Immediate-Release Fentanyl (TIRF) REMS

Advise patients of the following information pertaining to the TIRF REMS:

  • Inform outpatients that they must be enrolled in the TIRF REMS Access program before they can receive ABSTRAL.
  • Allow patients the opportunity to ask questions and discuss any concerns regarding ABSTRAL or the TIRF REMS Access program.
  • As required by the TIRF REMS Access program, review the contents of the ABSTRAL Medication Guide with every patient before initiating treatment with ABSTRAL.
  • Advise the patient that ABSTRAL is available only from pharmacies that are enrolled in the TIRF REMS Access program, and provide them with the telephone number and website for information on how to obtain the drug.
  • Advise the patient that only enrolled healthcare providers may prescribe ABSTRAL.
  • Inform the patient that they must sign the Patient-Prescriber Agreement to acknowledge that they understand the risks of ABSTRAL.
  • Advise patients that they may be requested to participate in a survey to evaluate the effectiveness of the TIRF REMS Access program [see Warnings and Precautions (5.7)].

Serotonin Syndrome

Inform patients that opioids could cause a rare and potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take, serotonergic medications. [see Warnings and Precautions (5.10), Drug Interactions (7)].

MAOI Interaction

Inform patients to avoid taking ABSTRAL while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking ABSTRAL [see Warnings and Precautions (5.10), Drug Interactions (7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.11)].

Important Administration Instructions [see Dosage and Administration (2)]

  • Instruct patients not to take ABSTRAL for acute pain, postoperative pain, pain from injuries, headache, migraine or any other short-term pain, even if they have taken other opioid analgesics for these conditions.
  • Inform patients on the meaning of opioid tolerance and that ABSTRAL is only to be used as a supplemental pain medication for patients with pain requiring around-the-clock opioids, who have developed tolerance to the opioid medication, and who need additional opioid treatment of breakthrough pain episodes.
  • Advise patients that, if they are not taking an opioid medication on a regular around-the-clock basis, they must not take ABSTRAL.
  • Instruct patients to place ABSTRAL tablets on the floor of the mouth directly under the tongue immediately after removal from the blister unit.
  • Instruct patients not to chew, suck, or swallow ABSTRAL tablets.
  • Instruct patients to allow ABSTRAL tablets to completely dissolve in the sublingual cavity.
  • Advise patients not to eat or drink anything until the tablet is completely dissolved [see Dosage and Administration (2.4), ABSTRAL Medication Guide].
  • In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking ABSTRAL. Instruct patients not to take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
  • Instruct patients to wait two hours before treating a new episode of breakthrough pain with
  • ABSTRAL.
  • Instruct patients NOT to share ABSTRAL and that sharing ABSTRAL with anyone else could result in the other individual's death due to overdose.
  • Instruct patients to use ABSTRAL exactly as prescribed by their doctor and not to take ABSTRAL more often than prescribed.

Hypotension

Inform patients that ABSTRAL may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.12)].

Anaphylaxis

Inform patients that anaphylaxis have been reported with ingredients contained in ABSTRAL. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform patients that prolonged use of ABSTRAL during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that ABSTRAL can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see Use in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].

Driving or Operating Heavy Machinery

Inform patients that ABSTRAL may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.16)].

Constipation

Advise patients of the potential for severe constipation and when to seek medical attention [see Adverse Reactions (6)].

Disposal of Unused ABSTRAL

  • Advise patients and their household members to dispose of any unopened packs remaining from a prescription as soon as they are no longer needed.
  • Instruct patients that, to dispose of any unused ABSTRAL tablets, remove them from the blister cards and flush them down the toilet. Do not dispose of the ABSTRAL blister cards or cartons down the toilet.
  • Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of ABSTRAL are provided in the ABSTRAL Medication Guide. Ensure patients read this information in its entirety and give them an opportunity to have their questions answered.
  • In the event that a caregiver requires additional assistance in disposing of excess units that remain in the home after the drug is no longer needed, instruct them to call the toll-free number for Sentynl Therapeutics, Inc. 1-888-227-8725 or seek assistance from their local DEA office.

Manufactured by:
Pharmaceutics International, Inc.
Hunt Valley, MD 21031

Manufactured for and Distributed by:
Sentynl Therapeutics, Inc.
Solana Beach, CA 92075

Medication Guide

ABSTRAL® (AB-stral) CII

(fentanyl)

Sublingual tablets

IMPORTANT:
Do not use ABSTRAL® unless you are regularly using another opioid pain medicine around-the-clock, for at least one week or longer, for your cancer pain, and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.
Keep ABSTRAL® in a safe place away from children. Get emergency medical help right away if:
  • A child takes ABSTRAL®. ABSTRAL® can cause an overdose and death in any child who takes it.
  • An adult who has not been prescribed ABSTRAL®, takes it.
  • An adult who is not already taking opioids around-the-clock, takes ABSTRAL®.
These are medical emergencies that can cause death. If possible, try to remove ABSTRAL® from the mouth.
ABSTRAL® is:
  • A strong prescription pain medicine that contains an opioid (narcotic) and is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. ABSTRAL® is started only after you have been taking other opioid pain medicines and your body has become used to them (i.e., you are opioid tolerant). Do not use ABSTRAL® if you are not opioid tolerant.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about ABSTRAL®:

  • Get emergency help right away if you take too much ABSTRAL® (overdose). When you first start taking ABSTRAL®, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur.
  • Taking ABSTRAL® with other opioid medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs, can cause severe drowsiness, confusion, breathing problems, coma, and death.
  • Never give anyone else your ABSTRAL®. They could die from taking it. Store ABSTRAL® away from children and in a safe place to prevent stealing or abuse. Selling or giving away ABSTRAL® is against the law.
  • If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using ABSTRAL®. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  • ABSTRAL® is available only through a program called the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive ABSTRAL®, you must:
    • Talk to your healthcare provider
    • Understand the benefits and risks of ABSTRAL®
    • Agree to all of the instructions
    • Sign the Patient-Prescriber Agreement form
  • ABSTRAL® is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your ABSTRAL® prescription filled.
  • Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti- depressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Do not take ABSTRAL® if:
  • You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock, for at least one week or longer, for your cancer pain, and your body is used to these medicines.
  • You have severe asthma, trouble breathing, or other lung problems.
  • You have a bowel blockage or have narrowing of the stomach or intestines.
  • You are allergic to any of the ingredients in ABSTRAL®. See the end of this Medication Guide for a complete list of ingredients in ABSTRAL®.
  • You have short-term pain that you would expect to go away in a few days, such as:
    • Pain after surgery
    • Headache or migraine
    • Dental pain
Before taking ABSTRAL®, tell your healthcare provider if you have a history of:
  • Troubled breathing or lung problems such as asthma, wheezing, or shortness of breath.
  • Head injury or seizures.
  • Slow heart rate or other heart problems.
  • Low blood pressure.
  • Mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)].
  • Problems urinating.
  • Liver, kidney, thyroid problems.
  • Pancreas or gallbladder problems.
  • Abuse of street or prescription drugs, alcohol addiction, or other mental health problems.

Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of ABSTRAL® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. ABSTRAL® passes into breast milk and may harm your baby.
  • Taking prescription over-the-counter medicines, vitamins, or herbal supplements. Taking ABSTRAL® with certain other medicines can cause serious side effects that could lead to death.
When taking ABSTRAL®:
  • Do not change your dose. Take ABSTRAL® exactly as prescribed by your healthcare provider.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
  • See the detailed Instructions for Use at the end of this Medication Guide for information about how to use ABSTRAL®.
  • Use ABSTRAL® tablets whole.
  • Do not crush, split, suck, or chew ABSTRAL® tablets, or swallow the tablets whole. You will get less relief for your breakthrough cancer pain.
  • Wait 30 minutes after using ABSTRAL®. If there is any of the ABSTRAL tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.
  • You must not use more than 2 doses of ABSTRAL® for each episode of breakthrough cancer pain.
  • Use 1 dose of ABSTRAL for an episode of breakthrough cancer pain.
  • If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of ABSTRAL®, you can use only 1 more dose of ABSTRAL®, as instructed by your healthcare provider.
  • If your breakthrough pain does not get better after the second dose of ABSTRAL®, call your healthcare provider for instructions. Do not use another dose of ABSTRAL® at this time.
  • Wait at least 2 hours before treating a new episode of breakthrough cancer pain with ABSTRAL®.
  • If you only need to take 1 dose of ABSTRAL® for an episode of breakthrough pain, you must wait 2 hours from the time of that dose to take a dose of ABSTRAL for a new episode of breakthrough pain.
  • If you need to use 2 doses of ABSTRAL® for an episode of breakthrough pain, you must wait 2 hours after the second dose to take a dose of ABSTRAL® for a new episode of breakthrough pain.
  • It is important for you to keep taking your around-the-clock opioid pain medicine while using
  • ABSTRAL®.
  • Talk to your healthcare provider if your dose of ABSTRAL® does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of ABSTRAL® needs to be changed.
  • Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
  • If you begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.
  • Do not stop taking ABSTRAL® without talking to your healthcare provider.
  • After you stop taking ABSTRAL®, or when it is no longer needed, see the section titled “How should I dispose of unused ABSTRAL® tablets when they are no longer needed?” for proper disposal of ABSTRAL®.
  • DO NOT drive or operate heavy machinery, until you know how ABSTRAL affects you. ABSTRAL can make you sleepy, dizzy, or lightheaded.
  • DO NOT drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ABSTRAL® may cause you to overdose and die.
  • DO NOT switch from ABSTRAL® to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of ABSTRAL® is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL® that may be different than other medicines containing fentanyl that you may have been taking.

How should I store ABSTRAL®?

  • Always keep ABSTRAL® in a safe place away from children and from anyone for whom it has not been prescribed. Protect ABSTRAL® from theft.
  • Store ABSTRAL® at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
  • Keep ABSTRAL® in the original blister unit. Do not remove ABSTRAL® tablets from their blister packaging for storage in a temporary container, such as a pillbox.

How should I dispose of unopened ABSTRAL® tablets when they are no longer needed?

  • Dispose of any unopened ABSTRAL® units remaining from a prescription as soon as you no longer need them.
    • Remove the tablets from the blister cards and flush them down the toilet.
  • Do not flush the ABSTRAL® blister cards, units, or cartons down the toilet.
  • If you need help with disposal of ABSTRAL®, call 1-888-227-8725 or call your local Drug Enforcement Agency (DEA) office.

General information about ABSTRAL®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ABSTRAL® only for the purpose for which it was prescribed. Do not give ABSTRAL® to other people, even if they have the same symptoms you have. ABSTRAL® can harm other people and even cause death. Sharing ABSTRAL® is against the law.

This Medication Guide summarizes the most important information about ABSTRAL®. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about ABSTRAL® that is written for healthcare professionals. For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1- 866-822-1483.

What are the ingredients in ABSTRAL®?

Active Ingredient: fentanyl citrate

Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose

Patient Instructions for Use

Before you take ABSTRAL®, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you take ABSTRAL® the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to take ABSTRAL®.

When you get an episode of breakthrough pain, take the dose prescribed by your healthcare provider as follows:

  • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle ABSTRAL® tablets.
  • ABSTRAL® comes in a blister card with 4 blister units. Each blister unit contains an ABSTRAL® tablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.
  • When you are ready to take an ABSTRAL® tablet, pull apart 1 of the blister units from the blister card by tearing along the dotted lines (perforations) until it is fully separated (See Figures 1 and 2).
  • When the blister unit is fully separated, peel back the foil starting at the unsealed area where indicated. Gently remove the tablet. Do not try to push ABSTRAL® tablets through the foil. This will damage the tablet (See Figures 3 and 4).
  • As soon as you remove the ABSTRAL® tablet from the blister unit:
    • Place it on the floor of your mouth, under your tongue, as far back as you can (See Figures 5, 6, and 7).
    • If more than 1 tablet is required, spread them around the floor of your mouth under your tongue.
    • Let the tablet dissolve completely. ABSTRAL® dissolves under your tongue and will be absorbed by your body to help provide relief for your breakthrough cancer pain.
    • Do not suck, chew or swallow the tablet.
    • You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.

Manufactured by:
Pharmaceutics International, Inc. Hunt Valley, MD 21031

Manufactured for:
Sentynl Therapeutics, Inc. Solana Beach, CA 92075

Issued: May 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Copyright © 2017, Sentynl Therapeutics, Inc. All rights reserved.

ABSTRAL® and Sentynl Therapeutics, Inc. are trademarks owned by the Sentynl Therapeutics, Inc.

Principal Display Panel - 100 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 100 mcg fentanyl base

NDC 42358-100-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

Principal Display Panel - 200 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 200 mcg fentanyl base

NDC 42358-200-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

Principal Display Panel - 300 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 300 mcg fentanyl base

NDC 42358-300-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

Principal Display Panel - 400 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 400 mcg fentanyl base

NDC 42358-400-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

Principal Display Panel - 600 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 600 mcg fentanyl base

NDC 42358-600-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

Principal Display Panel - 800 mcg Carton Label

ABSTRAL®CII

(fentanyl) sublingual tablets

equivalent to 800 mcg fentanyl base

NDC 42358-800-32 Rx only

32 Sublingual Tablets

(4 Tablets x 8 cards)

ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-100
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 100 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 1
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-100-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-200
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 200 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code 2
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-200-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-300
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 300 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape TRIANGLE (TRIANGLE) Size 10mm
Flavor Imprint Code 3
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-300-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-400
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 400 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape DIAMOND (DIAMOND) Size 10mm
Flavor Imprint Code 4
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-400-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-600
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 600 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape SEMI-CIRCLE (SEMI-CIRCLE (D--SHAPE)) Size 10mm
Flavor Imprint Code 6
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-600-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
ABSTRAL   FENTANYL
fentanyl citrate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42358-800
Route of Administration SUBLINGUAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fentanyl citrate (fentanyl) fentanyl 800 ug
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
magnesium stearate  
mannitol  
cellulose, microcrystalline  
Product Characteristics
Color white ( WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 10mm
Flavor Imprint Code 8
Contains     
Packaging
# Item Code Package Description
1 NDC:42358-800-32 8 BLISTER PACK in 1 CARTON
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022510 10/01/2016
Labeler - Sentynl Therapeutics, Inc. (078313706)
Establishment
Name Address ID/FEI Operations
Pharmaceutics International, Inc. 878265586 MANUFACTURE(42358-100, 42358-200, 42358-300, 42358-400, 42358-600, 42358-800)
Establishment
Name Address ID/FEI Operations
Sharp Packaging Solutions 143696495 PACK(42358-100, 42358-200, 42358-300, 42358-400, 42358-600, 42358-800)
Revised: 05/2017   Sentynl Therapeutics, Inc.
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