Abatacept

Do not receive a "live" vaccine while using abatacept, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with abatacept. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, night sweats, flu symptoms, weight loss;

• feeling very tired;

• dry cough, sore throat; or

• warmth, pain, or redness of your skin.

Call your doctor at once if you have any of these other serious side effects:

• trouble breathing;

• stabbing chest pain, wheezing, cough with yellow or green mucus;

• pain or burning when you urinate; or

• signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Common side effects may include:

• fever;

• nausea, diarrhea, stomach pain;

• headache; or

• cold symptoms such as stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vaccines

Data not available on the effects of immunization in patients receiving abatacept.1

Avoid live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, poliovirus vaccine live oral [no longer commercially available in US], smallpox vaccine, typhoid vaccine live oral, varicella vaccine live, yellow fever vaccine).1 No data available on secondary transmission of infection by live virus vaccines in abatacept-treated patients.1 Since abatacept may interfere with the immune response to antigens, vaccine efficacy may be reduced in patients receiving the drug.1 (See Vaccination under Cautions and see Pediatric Use under Cautions.)

Specific Drugs and Laboratory Tests

Absorption

Following multiple IV infusions, steady-state serum concentrations reached at 60 days.1 Systemic accumulation does not appear to occur.1

Elimination

Half-life

Terminal half-life averages 13.1 days.1

Special Populations

Age and gender (adjusted for body weight) do not affect clearance.1

Clearance increases with increasing body weight.1

Pharmacokinetics not evaluated in patients with hepatic or renal impairment.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• BMS-188667
• CTLA-4Ig

Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.

Contains maltose; may result in falsely elevated blood glucose levels with dehydrogenase pyrroloquinolinequinone or glucose-dye-oxidoreductase testing methods on the day of infusion. Glucose monitoring methods which utilize glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase are recommended.

Frequency not always defined; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)

>10%:

Central nervous system: Headache (≤18%)

Gastrointestinal: Nausea

Immunologic: Antibody development (2% to 41%)

Infection: Infection (adults 54%; children 36%)

Respiratory: Nasopharyngitis (12%), upper respiratory tract infection

1% to 10%:

Cardiovascular: Hypertension (7%)

Central nervous system: Dizziness (9%)

Dermatologic: Skin rash (4%)

Gastrointestinal: Dyspepsia (6%), abdominal pain, diarrhea

Genitourinary: Urinary tract infection (6%)

Immunologic: Immunogenicity (1% to 2%)

Infection: Herpes simplex infection, influenza

Local: Injection site reaction (3% to 4%)

Neuromuscular & skeletal: Back pain (7%), limb pain (3%)

Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis

Miscellaneous: Infusion-related reaction (≤9%), fever

<1%, postmarketing, and/or case reports: Acute lymphocytic leukemia, anaphylactoid reaction, anaphylaxis, cellulitis, diverticulitis, dyspnea, exacerbation of arthritis, exacerbation of chronic obstructive pulmonary disease, flushing, hypersensitivity reaction, hypotension, joint wear, malignant lymphoma, malignant melanoma, malignant neoplasm of bile duct, malignant neoplasm of bladder, malignant neoplasm of breast, malignant neoplasm of cervix, malignant neoplasm of kidney, malignant neoplasm of lung, malignant neoplasm of prostate, malignant neoplasm of skin, malignant neoplasm of thyroid, malignant neoplasm of uterus, myelodysplastic syndrome, ovarian cyst, pruritus, pyelonephritis, rhonchi, urticaria, varicella, vasculitis (including cutaneous vasculitis and leukocytoclastic vasculitis), wheezing

Orencia

• Store abatacept in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep abatacept in the original package and out of the light.
• Do not freeze this medication.
• Safely throw away medicine that is out of date or no longer needed.
• Keep abatacept and all medicines out of the reach of children.

Applies to abatacept: powder for solution, solution

Along with its needed effects, abatacept may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking abatacept:

• Back pain
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• cough producing mucus
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• headache
• loss of voice
• lower back or side pain
• nausea or vomiting
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest
• troubled breathing
• unusual tiredness or weakness

• Blurred vision
• burning or stinging of the skin
• chest pain
• nervousness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pounding in the ears
• skin rash
• slow or fast heartbeat

• Confusion
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• flushing
• hives or welts
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• stomach pain or tenderness
• sweating
• swelling of the face, throat, or tongue

• Redness, soreness, or itching of the skin
• sores, welts, blisters

Some side effects of abatacept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• heartburn
• indigestion
• stomach discomfort or upset

• Diarrhea
• pain in the arms or legs

IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer as a 30-minute IV infusion; repeat the dose 2 and 4 weeks after the initial dose, then every 4 weeks thereafter.

SUBCUTANEOUS:
125 mg subcutaneously once a week (without an IV loading dose)

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Summary of Use during Lactation

No information is available on the use of abatacept during breastfeeding. Abatacept is a large protein molecule with a molecular weight of 92,000. Only small amounts at most would be expected to enter breastmilk. If abatacept is required by the mother, it is not a reason to discontinue breastfeeding.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Rheumatoid Arthritis) Auranofin, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine

References

1. Gotestam Skorpen C, Hoeltzenbein M, Tincani A et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795-810. PMID: 26888948