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Depression and Suicide

Rebif® (interferon beta-1a) should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif® (interferon beta-1a) . In addition, there have been postmarketing reports of suicide in patients treated with Rebif® (interferon beta-1a) . Patients should be advised to report immediately any symptoms of depression and/or suicidal ideation to the prescribing physician. If a patient develops depression, cessation of treatment with Rebif® (interferon beta-1a) should be considered.

Hepatic Injury

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif® (interferon beta-1a) . Symptoms of liver dysfunction began from one to six months following the initiation of Rebif® (interferon beta-1a) . If jaundice or other symptoms of liver dysfunction appear, treatment with Rebif® (interferon beta-1a) should be discontinued immediately due to the potential for rapid progression to liver failure.

Asymptomatic elevation of hepatic transaminases (particularly SGPT) is common with interferon therapy (see ADVERSE REACTIONS). Rebif® (interferon beta-1a) should be initiated with caution in patients with active liver disease, alcohol abuse, increased serum SGPT ( > 2.5 times ULN), or a history of significant liver disease. Also, the potential risk of Rebif® (interferon beta-1a) used in combination with known hepatotoxic products should be considered prior to Rebif® (interferon beta-1a) administration, or when adding new agents to the regimen of patients already on Rebif® (interferon beta-1a) . Reduction of Rebif® (interferon beta-1a) dose should be considered if SGPT rises above 5 times the upper limit of normal. The dose may be gradually re-escalated when enzyme levels have normalized. (see PRECAUTIONS: Laboratory Tests and DRUG INTERACTIONS; and DOSAGE AND ADMINISTRATION).

Anaphylaxis

Anaphylaxis has been reported as a rare complication of Rebif® (interferon beta-1a) use. Other allergic reactions have included skin rash and urticaria, and have ranged from mild to severe without a clear relationship to dose or duration of exposure. Several allergic reactions, some severe, have occurred after prolonged use.

Albumin (Human)

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt- Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

General

Caution should be exercised when administering Rebif® (interferon beta-1a) to patients with pre-existing seizure disorders. Seizures have been associated with the use of beta interferons including Rebif® (interferon beta-1a) . Leukopenia and new or worsening thyroid abnormalities have developed in some patients treated with Rebif® (see ADVERSE REACTIONS). Regular monitoring for these conditions is recommended (see PRECAUTIONS: Laboratory Tests).

Information for Patients

All patients should be instructed to read the Rebif® Medication Guide supplied to them. Patients should be cautioned not to change the dosage or the schedule of administration without medical consultation. Patients should be informed of the most common and the most severe adverse reactions associated with the use of Rebif® (see WARNINGS and ADVERSE REACTIONS). Patients should be advised of the symptoms associated with these conditions, and to report them to their physician.

Female patients should be cautioned about the abortifacient potential of Rebif® (interferon beta-1a) (see PRECAUTIONS: Pregnancy).

Patients should be instructed in the use of aseptic technique when administering Rebif® (interferon beta-1a) . Appropriate instruction for self-injection or injection by another person should be provided, including careful review of the Rebif® (interferon beta-1a) Medication Guide. If a patient is to selfadminister Rebif® (interferon beta-1a) , the physical and cognitive ability of that patient to self-administer and properly dispose of syringes should be assessed. The initial injection should be performed under the supervision of an appropriately qualified health care professional. Patients should be advised of the importance of rotating sites of injection with each dose, to minimize the likelihood of severe injection site reactions or necrosis. A punctureresistant container for disposal of used needles and syringes should be supplied to the patient along with instructions for safe disposal of full containers. Patients should be instructed in the technique and importance of proper syringe disposal and be cautioned against reuse of these items.

Laboratory Tests

In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, blood cell counts and liver function tests are recommended at regular intervals (1, 3, and 6 months) following introduction of Rebif® (interferon beta-1a) therapy and then periodically thereafter in the absence of clinical symptoms. Thyroid function tests are recommended every 6 months in patients with a history of thyroid dysfunction or as clinically indicated. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: No carcinogenicity data for Rebif® (interferon beta-1a) are available in animals or humans.

Mutagenesis: Rebif® (interferon beta-1a) was not mutagenic when tested in the Ames bacterial test and in an in vitro cytogenetic assay in human lymphocytes in the presence and absence of metabolic activation.

Impairment of Fertility: No studies have been conducted to evaluate the effects of Rebif® (interferon beta-1a) on fertility in humans. In studies in normally cycling female cynomolgus monkeys given daily sc injections of Rebif® (interferon beta-1a) for six months at doses of up to 9 times the recommended weekly human dose (based on body surface area), no effects were observed on either menstrual cycling or serum estradiol levels. The validity of extrapolating doses used in animal studies to human doses is not established. In male monkeys, the same doses of Rebif® (interferon beta-1a) had no demonstrable adverse effects on sperm count, motility, morphology, or function.

Pregnancy Category C

Rebif® (interferon beta-1a) treatment has been associated with significant increases in embryolethal or abortifacient effects in cynomolgus monkeys administered doses approximately 2 times the cumulative weekly human dose (based on either body weight or surface area) either during the period of organogenesis (gestation day 21-89) or later in pregnancy. There were no fetal malformations or other evidence of teratogenesis noted in these studies. These effects are consistent with the abortifacient effects of other type I interferons. There are no adequate and wellcontrolled studies of Rebif® (interferon beta-1a) in pregnant women. However, in Studies 1 and 2, there were 2 spontaneous abortions observed and 5 fetuses carried to term among 7 women in the Rebif® (interferon beta-1a) groups. If a woman becomes pregnant or plans to become pregnant while taking Rebif® (interferon beta-1a) , she should be informed about the potential hazards to the fetus and discontinuation of Rebif® (interferon beta-1a) should be considered.

Nursing Mothers

It is not known whether Rebif® (interferon beta-1a) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Rebif® (interferon beta-1a) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Rebif® (interferon beta-1a) in pediatric patients have not been studied.

Geriatric Use

Clinical studies of Rebif® (interferon beta-1a) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 1/15/2010
This monograph has been modified to include the generic and brand name in many instances.