Soriatane

Soriatane

SIDE EFFECTS

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 Soriatane administration 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 Soriatane. 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

Nervous System

Myopathy with peripheral neuropathy has been reported during Soriatane therapy. 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 Soriatane. Since other factors may have contributed to these events, it is not known if they are related to Soriatane (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.

Clinical Trials

During clinical trials with Soriatane, 513/525 (98%) of patients reported a total of 3545 adverse events. One-hundred sixteen patients (22%) left studies prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three patients died. Two of the deaths were not drug related (pancreatic adenocarcinoma and lung cancer); the other patient died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, Soriatane 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 patients with psoriasis.

Table 3: Adverse Events Frequently Reported During Clinical Trials Percent of Patients 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
Sticky skin

Table 4: Adverse Events Less Frequently Reported During Clinical Trials (Some of Which May Bear No Relationship to Therapy) Percent of Patients 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

Soriatane therapy 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 patients treated with Soriatane. In most patients, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In patients receiving Soriatane 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 Patients Reporting

BODY SYSTEM 50% to 75% 25% to 50% 10% to 25% 1% to 10%
Electrolytes     Increased:
–Phosphorus
–Potassium
–Sodium
Decreased:
–Phosphorus
–Potassium
–Sodium
      Increased and decreased:
–Magnesium
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

Read the Soriatane (acitretin) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Ethanol

Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics).

Glibenclamide

In a study of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose lowering effect of glibenclamide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the study with 6 healthy male volunteers in the absence of glibenclamide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with Soriatane is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).

Hormonal Contraceptives

It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestinminipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with Soriatane (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). It is not known whether other progestational contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.

Methotrexate

An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see CONTRAINDICATIONS).

Phenytoin

If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.

Tetracyclines

Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see CONTRAINDICATIONS and WARNINGS: Pseudotumor Cerebri).

Vitamin A and oral retinoids

Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A.

Other

There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Laboratory Tests

If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.

Blood Sugar

Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, blood-sugar levels should be monitored very carefully.

Lipids

In clinical studies, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33% and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to Soriatane has stabilized (see WARNINGS).

Liver Function Tests

Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 patients treated with Soriatane. It is recommended that these tests be performed prior to initiation of Soriatane therapy, at 1-to 2-week intervals until stable and thereafter at intervals as clinically indicated (see CONTRAINDICATIONS and BOXED WARNINGS).

Read the Soriatane Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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