Acitretin Capsules

Name: Acitretin Capsules

Acitretin Capsules Description

Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is:

Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black).

Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).

Clinical Studies

In 2 double-blind, placebo-controlled trials, acitretin was administered once daily to subjects with severe psoriasis (e.g., covering at least 10% to 20% of the body surface area). At 8 weeks (see Table 1) subjects treated in Trial A with 50 mg of  acitretin per day showed significant improvements (P ≤ 0.05) relative to baseline and to placebo in the physician’s global evaluation and in the mean ratings of severity of psoriasis (scaling, thickness, and erythema). In Trial B, differences from baseline and from placebo were statistically significant (P ≤ 0.05) for all variables at both the 25 mg and 50 mg doses; it should be noted for Trial B that no statistical adjustment for multiplicity was carried out.

Table 1. Summary of the Efficacy Results of the 8-Week Double-Blind Phase of Trials A and B of Acitretin

 

Efficacy Variables

 

Trial A

 

Trial B

 

Total Daily Dose

 

Total Daily Dose

 

Placebo

(N = 29)

 

50 mg

(N = 29)

 

Placebo

(N = 72)

 

25 mg

(N = 74)

 

50 mg

(N = 71)

 

Physician’s

Global Evaluation

Baseline

Mean Change

After 8 Weeks

4.62

−0.29

 

4.55

−2.00a

 

4.43

−0.06

4.37

−1.06a

 

4.49

−1.57a

 

Scaling

Baseline

Mean Change

After 8 Weeks

 

4.10

−0.22

 

3.76

−1.62a

 

3.97

−0.21

 

4.11

−1.50a

 

4.10

−1.78a

 

Thickness

Baseline

Mean Change

After 8 Weeks

 

4.10

−0.39

 

4.10

−2.10a

 

4.03

−0.18

 

4.11

−1.43a

 

4.20

−2.11a

 

Erythema

Baseline

Mean Change

After 8 Weeks

 

4.21

−0.33

 

4.59

−2.10a

 

4.42

−0.37

 

4.24

−1.12a

 

4.45

−1.65a

aValues were statistically significantly different from placebo and from baseline (P ≤ 0.05). No adjustment for multiplicity was done for Trial B.  The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physician’s global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a 7-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).

A subset of 141 subjects from both pivotal Trials A and B continued to receive acitretin in an open fashion for up to 24 weeks. At the end of the treatment period, all efficacy variables, as indicated in Table 2, were significantly improved (P ≤ 0.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity, and physician’s global evaluation.

Table 2. Summary of the First Course of Therapy with Acitretin (24 Weeks)

 

Variables

 

Trial A

 

Trial B

 

Mean Total Daily Dose of Acitretin (mg)

 

42.8

 

43.1

 

Mean Duration of Therapy (Weeks)

 

21.1

 

22.6

 

Physician’s Global Evaluation

Baseline

Mean Change From Baseline

 

N=39

4.51

 −2.26a

 

N=98

4.43

 −2.60a

 

Scaling

Baseline

Mean Change From Baseline

 

N=59

3.97

 −2.15a

 

N=132

4.07

−2.42a

 

Thickness

Baseline

Mean Change From Baseline

 

N=59

4.00

−2.44a

 

N=132

4.12

−2.66a

 

Erythema

Baseline

Mean Change From Baseline

 

N=59

4.35

−2.31a

 

N=132

4.33

−2.29a

a Indicates that the difference from baseline was statistically significant (P ≤ 0.01).

The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physician’s global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a 7-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).

All efficacy variables improved significantly in a subset of 55 subjects from Trial A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of subjects (n=4) from Trial A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).

Adverse Reactions

Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome.

Adverse Events/Postmarketing Reports:

In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular:

Acute myocardial infarction, thromboembolism (see WARNINGS), stroke.

Immune System Disorders:  

Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS).

Nervous System:

Myopathy with peripheral neuropathy has been reported during therapy with acitretin. Both conditions improved with discontinuation of the drug.

Psychiatric:

Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking acitretin. Since other factors may have contributed to these events, it is not known if they are related to acitretin (see PRECAUTIONS).

Reproductive:

Vulvo-vaginitis due to Candida albicans.

Skin and Appendages:

Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported (see WARNINGS).

Vascular Disorders:Capillary leak syndrome (see WARNINGS).

Clinical Trials:

During clinical trials with acitretin, 513 of 525 (98%) subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, acitretin was associated with elevations in liver function test results or triglyceride levels and hepatitis.

The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.

Table 3. Adverse Events Frequently Reported during Clinical Trials
Percent of Subjects Reporting (N = 525)

  Body System  >75%   50% to 75%  25% to 50%  10% to 25% 
  CNS           Rigors 
  Eye Disorders           Xerophthalmia
 Mucous
Membranes
  Cheilitis     Rhinitis   

Dry mouth
Epistaxis

  Musculoskeletal            Arthralgia
Spinal hyperostosis
(progression
of existing
lesions)
 Skin and Appendages     Alopecia
Skin peeling
 

Dry skin
Nail disorder
Pruritus

 Erythematous
rash
Hyperesthesia
Paresthesia
Paronychia
Skin atrophy
Skicky skin

Table 4. Adverse Events Less Frequently Reported during Clinical Trials (Some of Which  
May Bear No Relationship to Therapy) Percent of Subjects Reporting (N = 525)

 

Body System

 

1% to 10%

 

<1%

 

Body as a Whole

 

Anorexia
Edema
Fatigue
Hot flashes
Increased appetite

   

Alcohol                  
intolerance            
Dizziness              
Fever                     
Influenza-like
symptoms

 Malaise
Moniliasis
Muscle weakness
Weight increase
 

Cardiovascular

 

Flushing

   

Chest pain                
Cyanosis                  
Increased                   
bleeding time             

 Intermittent
claudication
Peripheral
ischemia
 

CNS (also see
Psychiatric)

 

Headache
Pain

   

Abnormal gait            
Migraine                    
Neuritis                     
                                  

 Pseudotumor
cerebri
(intracranial
hypertension)
 

Eye Disorders

Abnormal/ blurred vision Blepharitis Conjunctivitis/ irritation

Corneal epithelial abnormality

Decreased night vision/night blindness Eye abnormality Eye pain Photophobia Abnormal              
lacrimation               
Chalazion                
Conjunctival            
hemorrhage              
Corneal ulceration
Diplopia
Ectropion
 Itchy eyes and lids
Papilledema
Recurrent sties
Subepithelial
corneal lesions
 

Gastrointestinal

 

Abdominal pain
Diarrhea
Nausea
Tongue disorder

   

Constipation           
Dyspepsia               
Esophagitis             
Gastritis                  
Gastroenteritis        

 Glossitis
Hemorrhoids
Melena
Tenesmus
Tongue ulceration
  Liver and Biliary      Hepatic function
abnormal
Hepatitis
Jaundice
  
 

Mucous Membranes

Gingival bleeding Gingivitis Increased saliva

Stomatitis Thirst Ulcerative stomatitis

Altered saliva        
Anal disorder         
Gum hyperplasia

 Hemorrhage
Pharyngitis
 

Musculoskeletal

Arthritis Arthrosis Back pain Hypertonia Myalgia

Osteodynia Peripheral joint hyperostosis (progression of existing lesions) Bone disorder
Olecranon bursitis
Spinal
hyperostosis
(new lesions)
Tendonitis
  
 

Psychiatric

 

Depression
Insomnia
Somnolence

   

Anxiety
Dysphonia
Libido decreased
Nervousness

  
 Reproductive      Atrophic vaginitis
Leukorrhea
  
 

Respiratory

 

Sinusitis

   

Coughing
Increased sputum
Laryngitis

  
 

Skin and
Appendages

Abnormal skin odor

Abnormal hair texture

Bullous eruption Cold/clammy skin Dermatitis Increased

sweating

Infection                 

Psoriasiform rash

Purpura Pyogenic granuloma Rash Seborrhea Skin fissures

Skin ulceration

Sunburn

Acne                           
Breast pain                  
Cyst                           
Eczema                       
Fungal infection          
Furunculosis                
Hair discoloration        
Herpes simplex            
Hyperkeratosis           
Hypertrichosis             
Hypoesthesia              
Impaired healing         
Otitis media                
                                   
 Otitis externa
Photosensitivity
reaction
Psoriasis
aggravated
Scleroderma
Skin nodule
Skin hypertrophy
Skin disorder
Skin irritation
Sweat gland
disorder
Urticaria
Verrucae
 

Special Senses/
Other

 

Earache
Taste perversion
Tinnitus

   

Ceruminosis
Deafness
Taste loss

  
 Urinary       

Abnormal urine
Dysuria
Penis disorder

  

Laboratory:

Therapy with acitretin induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 subjects treated with acitretin. In most subjects, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In subjects receiving acitretin during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.

Table 5 lists the laboratory abnormalities reported during clinical trials.

    Table 5. Abnormal Laboratory Test Results Reported during Clinical Trials
     Percent of Subjects Reporting

 

Body System

 

50% to 75%

 

25% to 50%

 

10% to 25%

 

1% to 10%

 

Electrolytes

      Increased:
–Phosphorus
–Potassium
–Sodium
Increased and decreased:
–Magnesium
Decreased:
–Phosphorus
–Potassium
–Sodium

Increased and decreased:
–Calcium
–Chloride

 

Hematologic

   Increased:
–Reticulocytes
Decreased:
–Hematocrit
–Hemoglobin
–WBC Increased:
–Haptoglobin
–Neutrophils
–WBC

Increased:
–Bands
–Basophils
–Eosinophils
–Hematocrit
–Hemoglobin
–Lymphocytes
–Monocytes

Decreased:
–Haptoglobin
–Lymphocytes
–Neutrophils
–Reticulocytes
Increased or decreased:
–Platelets
–RBC

  Hepatic    Increased:
–Cholesterol
–LDH
–SGOT
–SGPT Decreased:
–HDL cholesterol
Increased:
–Alkaline   phosphatase
–Direct bilirubin
–GGTP
Increased:
–Globulin
–Total bilirubin
–Total protein
Increased and
decreased:
–Serum albumin
 

Miscellaneous

 

Increased:
–Triglycerides

 

Increased:
–CPK
–Fasting blood sugar

 

Decreased:
–Fasting blood sugar
–High occult blood

 

Increased and
decreased:
–Iron

 Renal        

Increased:
–Uric acid

 

Increased:
–BUN
–Creatinine

 Urinary      WBC in urine  

Acetonuria
Hematuria
RBC in urine

 

Glycosuria
Proteinuria

To report SUSPECTED ADVERSE EVENTS, contact Impax Laboratories, Inc. at 1-877-994-6729 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

How is Acitretin Capsules Supplied

White to off-white body and a brown cap, 10 mg, imprinted in black “WPI” on the capsule cap and “2263” on the capsule body; bottles of 30 (NDC 0115-1667-08).

Yellow to light yellow body and cap, 17.5 mg, imprinted in black “WPI” on the capsule cap and “2264” on the capsule body; bottles of 30 (NDC 0115-1668-08).

Brown body and cap, 22.5 mg, imprinted in black with “WPI” on the capsule cap and “2265” on the capsule body; bottles of 30 (NDC 0115-1698-08).  

Yellow to light yellow body and a brown cap, 25 mg, imprinted in black “WPI” on the capsule cap and “2266” on the capsule body; bottles of 30 (NDC 0115-1669-08).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

MEDICATION GUIDE ACITRETIN (A-si-TRE-tin) CAPSULES, USP

Read this Medication Guide carefully before you start taking acitretin and read it each time you get more acitretin. There may be new information.

The first information in this Guide is about birth defects and how to avoid pregnancy. After this section there is important safety information about possible effects for any patient taking acitretin. ALL patients should read this entire Medication Guide carefully.

This information does not take the place of talking with your prescriber about your medical condition or treatment.

What is the most important information I should know about acitretin?

Acitretin can cause serious side effects, including:

1. Severe birth defects. If you are a female who can get pregnant, you should use acitretin only if you are not pregnant now, can avoid becoming pregnant for at least 3 years, and other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines.  Information about effects on unborn babies and about how to avoid pregnancy is found in the next section: “What are the important warnings and instructions for females taking acitretin?”

2. Liver problems, including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with acitretin. Stop taking acitretin and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem:

  • yellowing of your skin or the whites of your eyes
  • nausea and vomiting
  • loss of appetite
  • dark urine

 What are the important warnings and instructions for females taking acitretin?
• Before you receive your first prescription for acitretin, you should have discussed and signed a Patient Agreement/Informed Consent for Female Patients form with your prescriber. This is to help make sure you understand the risk of birth defects and how to avoid getting pregnant. If you did not talk to your prescriber about this and sign the form, contact your prescriber.
NOTE: If you are a female who can become pregnant:
• You must not take acitretin if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because acitretin can cause severe birth defects.
• During treatment with acitretin and for 2 months after you stop treatment with acitretin, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol. Avoiding alcohol is very important, because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin and for 2 months after you stop taking acitretin.
• You and your prescriber must be sure you are not pregnant before you start therapy with acitretin. You must have negative results from 2 pregnancy tests before you start treatment with acitretin. A negative result shows you are not pregnant. Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin until you have negative results from 2 pregnancy tests.
• The first pregnancy test (urine or blood) will be done at the time you and your prescriber decide if acitretin might be right for you.
• The second pregnancy test will usually be done during the first 5 days of your menstrual period.   You must start taking acitretin within 7 days of when the urine or blood for the second pregnancy test is collected.
• After you start taking acitretin, you must have a pregnancy test repeated each month that you are taking acitretin. This is to be sure that you are not pregnant during treatment because acitretin can cause birth defects.  In addition, your prescription of acitretin will be limited to a monthly supply.
• For at least 3 years after stopping treatment with acitretin, you must have a pregnancy test repeated every 3 months to make sure that you are not pregnant.
• Discuss effective birth control (contraception) with your prescriber. You must use 2 effective forms of birth control (contraception) at the same time during all of the following:
• for at least 1 month before beginning treatment with acitretin
• during treatment with acitretin
• for at least 3 years after stopping treatment with acitretin
• If you are sexually active, you must use 2 effective forms of birth control (contraception) at the same time even if you think you cannot become pregnant, unless 1 of the following is true for you:

  • You had your womb (uterus) removed during an operation (a hysterectomy).
  • Your prescriber said you have gone completely through menopause (the “change of life”).

• You can get a free birth control counseling session and pregnancy testing from a prescriber or family planning expert. Your prescriber can give you a Contraception Counseling Referral Form for this free session.

The following are considered effective forms of birth control:
Primary Forms:

  • having your tubes tied (tubal ligation)
  • partner's vasectomy
  • IUD (Intrauterine device)
  • Birth control pills that contain both estrogen and progestin (combination oral contraceptives); not progestin-only "minipills"
  • hormonal birth control products are injected, implanted, or inserted in your body
  • birth control patch

Secondary Forms (use with a Primary Form):

  • diaphragms with spermicide
  • condoms (with or without spermicide)
  • cervical caps with spermicide
  • vaginal sponge (contains spermicide)

At least 1 of your 2 methods of birth control must be a primary form.
• If you have sex at any time without using 2 effective forms of birth control (contraception) at the same time, or if you get pregnant or miss your period, stop using acitretin and call your prescriber right away.
• Consider “Emergency Contraception” (EC) if you have sex with a male without correctly using 2 effective forms of birth control (contraception) at the same time. EC is also called “emergency birth control” or the “morning after” pill. Contact your prescriber as soon as possible if you have sex without using 2 effective forms of birth control (contraception) at the same time, because EC works best if it is used within 1 or 2 days after sex. EC is not a replacement for your usual 2 effective forms of birth control (contraception) because it is not as effective as regular birth control methods.
You can get EC from private doctors or nurse practitioners, women’s health centers, or hospital emergency rooms. You can get the name and phone number of EC providers nearest you by calling the free Emergency Contraception Hotline at 1-866-245-6020 or www.not-2-late.com.
• Stop taking acitretin right away and contact your prescriber if you get pregnant while taking acitretin or at any time for at least 3 years after treatment has stopped. You need to discuss the possible effects on the unborn baby with your prescriber.
• If you do become pregnant while taking acitretin or at any time for at least 3 years after stopping acitretin, you should report your pregnancy to Impax Generics Medical Information Call Center at 1-877-994-6729 or directly to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088. Your name will be kept in private (confidential). The information you share will help the FDA and the manufacturer evaluate the Pregnancy Prevention Program for acitretin.
• Do not take acitretin if you are breastfeeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breastfeed or take acitretin, but not both.

What should males know before taking acitretin?
Small amounts of acitretin are found in the semen of males taking acitretin. Based upon available information, it appears that these small amounts of acitretin in semen pose little, if any, risk to an unborn child while a male patient is taking the drug or after it is discontinued. Discuss any concerns you have about this with your prescriber.
All patients should read the rest of this Medication Guide.
What is acitretin?
Acitretin is a medicine used to treat severe forms of psoriasis in adults. Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin’s surface. In the most common type of psoriasis, the skin becomes inflamed and produces red, thickened areas, often with silvery scales.
Because acitretin can have serious side effects, you should talk with your prescriber about whether possible benefits of acitretin outweigh its possible risks.
Acitretin may not work right away. You may have to wait 2 to 3 months before you get the full benefit of acitretin. Psoriasis gets worse for some patients when they first start treatment with acitretin.
Acitretin has not been studied in children.
Who should not take acitretin?
• Do NOT take acitretin if you can get pregnant. Do not take acitretin if you are pregnant or might get pregnant during treatment with acitretin or at any time for at least 3 years after you stop treatment with acitretin (see “What are the important warnings and instructions for females taking acitretin?”).
• Do NOT take acitretin if you are breastfeeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breastfeed or take acitretin, but not both.
• Do NOT take acitretin if you have severe liver or kidney disease.
• Do NOT take acitretin if you have repeated high blood lipids (fat in the blood).
• Do NOT take acitretin if you take these medicines:
• methotrexate
• tetracyclines
The use of these medicines with acitretin may cause serious side effects.
• Do NOT take acitretin if you are allergic to acitretin, the active ingredient in acitretin, to any of the other ingredients in acitretin (see the end of this Medication Guide for a list of all the ingredients in acitretin), or to any medicines that are like acitretin.  Ask your prescriber or pharmacist if any medicines you are allergic to are like acitretin.

Tell your prescriber if you have or ever had:

  • diabetes or high blood sugar
  • liver problems
  • kidney problems
  • High cholesterol or high triglycerides (fat in the blood)
  • heart disease
  • depression
  • alcoholism
  • an allergic reaction to a medication

Your prescriber needs this information to decide if acitretin is right for you and to know what dose is best for you.
Tell your prescriber about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines can cause serious side effects if taken while you also take acitretin. Some medicines may affect how acitretin works, or acitretin may affect how your other medicines work. Be especially sure to tell your prescriber if you are taking the following medicines:

  • methotrexate
  • tetracyclines
  • glyburide
  • phenytoin
  • vitamin A supplements
  • progestin-only oral contraceptives ("minipills")
  • TEGISON®  or TIGASON (etretinate). Tell your prescriber if you have ever taken this medicine in the past
  • St. John's wort herbal supplement

Tell your prescriber if you are getting phototherapy treatment. Your doses of phototherapy may need to be changed to prevent a burn.
How should I take acitretin?
• Take acitretin with food.
• Be sure to take your medicine as prescribed by your prescriber. The dose of acitretin varies from patient to patient. The number of capsules you must take is chosen specially for you by your prescriber. This dose may change during treatment.
• If you miss a dose, do not double the next dose. Skip the missed dose and resume your normal schedule.
• If you take too much acitretin (overdose), call your local poison control center or emergency room.
You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body’s response to acitretin. Your prescriber may also do other tests.
Once you stop taking acitretin, your psoriasis may return. Do not treat this new psoriasis with leftover acitretin. It is important to see your prescriber again for treatment recommendations because your situation may have changed.
What should I avoid while taking acitretin?
• Avoid pregnancy. See “What is the most important information I should know about acitretin?”, and “What are the important warnings and instructions for females taking acitretin?”
• Avoid breastfeeding. See “What are the important warnings and instructions for females taking acitretin?”
• Avoid alcohol. Females who are able to become pregnant must avoid drinks, foods, medicines, and over-the-counter products that contain alcohol. The risk of birth defects may continue for longer than 3 years if you swallow any form of alcohol during treatment with acitretin and for 2 months after stopping acitretin (see “What are the important warnings and instructions for females taking acitretin?”).
• Avoid giving blood. Do not donate blood while you are taking acitretin and for at least 3 years after stopping treatment with acitretin. Acitretin in your blood can harm an unborn baby if your blood is given to a pregnant woman. Acitretin does not affect your ability to receive a blood transfusion.
• Avoid progestin-only birth control pills (“minipills”). This type of birth control pill may not work while you take acitretin. Ask your prescriber if you are not sure what type of pills you are using.
• Avoid night driving if you develop any sudden vision problems. Stop taking acitretin and call your prescriber if this occurs (see “Serious side effects”).
• Avoid non-medical ultraviolet (UV) light. Acitretin can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.
• Avoid dietary supplements containing vitamin A. Acitretin is related to vitamin A. Therefore, do not take supplements containing vitamin A, because they may add to the unwanted effects of acitretin. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.
• DO NOT SHARE acitretin with anyone else, even if they have the same symptoms. Your medicine may harm them or their unborn child.
What are the possible side effects of acitretin?
Acitretin can cause serious side effects. See “What is the most important information I should know about acitretin?” and “What are the important warnings and instructions for females taking acitretin?”
Stop taking acitretin and call your prescriber right away if you get the following signs or symptoms of possible serious side effects:
• Bad headaches, nausea, vomiting, blurred vision. These symptoms can be signs of increased brain pressure that can lead to blindness or even death.
• Vision problems.  Decreased vision in the dark (night blindness). Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin stops. Stop taking acitretin and call your prescriber if you develop any vision problems or eye pain.
• Depression. There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). These events, including suicidal behavior, have been reported in patients taking other drugs similar to acitretin as well as patients taking acitretin. Since other things may have contributed to these problems, it is not known if they are related to acitretin.
• Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet. These can be signs of abnormal changes to your bones or muscles.
• Frequent urination, great thirst or hunger. Acitretin can affect blood sugar control, even if you do not already have diabetes. These are some of the signs of high blood sugar.
• Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke. Acitretin can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
• Blood vessel problems. Acitretin can cause fluid to leak out of your blood vessels into your body tissues. Call your prescriber right away if you have any of the following symptoms: sudden swelling in one part of your body or all over your body, weight gain, fever, lightheadedness or feeling faint, or muscle aches. If this happens, your prescriber will tell you to stop taking acitretin.
•  Serious allergic reactions. See “Who should not take acitretin?” Serious allergic reactions can happen during treatment with acitretin. Call your prescriber right away if you get any of the following symptoms of an allergic reaction: hives, itching, swelling of your face, mouth, or tongue, or problems breathing. If this happens, stop taking acitretin and do not take it again.
•  Serious skin problems. Acitretin can cause skin problems that can begin in a small area and then spread over large areas of your body. Call your prescriber right away if your skin becomes red and swollen (inflamed), you have peeling of your skin, or your skin becomes itchy and painful. You should stop acitretin if this happens.
Common side effects
If you develop any of these side effects or any unusual reaction, check with your prescriber to find out if you need to change the amount of acitretin you take. These side effects usually get better if the dose of acitretin is reduced or acitretin is stopped.
• Chapped lips, peeling fingertips, palms, and soles, itching, scaly skin all over, weak nails, sticky or fragile (weak) skin, runny or dry nose, or nosebleeds. Your prescriber or pharmacist can recommend a lotion or cream to help treat drying or chapping.
• Dry mouth
• Joint pain
• Tight muscles
• Hair loss. Most patients have some hair loss, but this condition varies among patients. No one can tell if you will lose hair, how much hair you may lose or if and when it may grow back.  You may also lose your eyelashes.
• Dry eyes. Acitretin may dry your eyes. Wearing contact lenses may be uncomfortable during and after treatment with acitretin because of the dry feeling in your eyes. If this happens, remove your contact lenses and call your prescriber. Also read the section about vision under “Serious side effects”.
• Rise in blood fats (lipids). Acitretin can cause your blood fats (lipids) to rise. Most of the time this is not serious. But sometimes the increase can become a serious problem (see information under “Serious side effects”). You should have blood tests as directed by your prescriber.
Psoriasis gets worse for some patients when they first start treatment with acitretin. Some patients have more redness or itching. If this happens, tell your prescriber. These symptoms usually get better as treatment continues, but your prescriber may need to change the amount of your medicine.
These are not all the possible side effects of acitretin. For more information, ask your prescriber or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store acitretin?

  • Keep acitretin away from sunlight, high temperature, and humidity.
  • Keep acitretin and all medicines out of the reach of children.

What are the ingredients in acitretin?
Active ingredient: acitretin.
Inactive ingredients:  microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).
General information about the safe and effective use of acitretin
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use acitretin for a condition for which it was not prescribed. Do not give acitretin to other people, even if they have the same symptoms that you have.
This Medication Guide summarizes the most important information about acitretin. If you would like more information, talk with your prescriber. You can ask your pharmacist or prescriber for information about acitretin that is written for health professionals.
For more information about acitretin call 1-877-994-6729 or go to www.acitretinEPPA.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
TEGISON® is a registered trademark of Hoffmann-La Roche Inc.

Manufactured by:
Micro-Sphere SA
Via Cantonale
CH-6996 Ponte Cremenaga
Lugano
Switzerland

Distributed by:
Impax Generics
Hayward, California 94544

Revised: November 2016
LA-1788-02

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