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Alferon N Injection (Interferon Alfa-N3) - Warnings and Precautions

 
 



WARNINGS

Because of the fever and other "flu-like" symptoms associated with Alferon N Injection® (See ADVERSE REACTIONS), it should be used cautiously in patients with debilitating medical conditions such as cardiovascular disease (e.g., unstable angina and uncontrolled congestive heart failure), severe pulmonary disease (e.g., chronic obstructive pulmonary disease), or diabetes mellitus with ketoacidosis. Alferon N Injection® should be used cautiously in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism and hemophilia), severe myelosuppression, or seizure disorders. Acute, serious hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have not been observed in patients receiving Alferon N Injection®. However, if such reactions develop, drug administration should be discontinued immediately and appropriate medical therapy should be instituted.

Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt Jakob disease (CJD) agent.

PRECAUTIONS

General --Patients being treated with Alferon N Injection® should be informed of the benefits and risks associated with the treatment. Because the manufacturing process, strength, and type of interferon (e.g., natural, human leukocyte interferon versus single-species recombinant interferon) may vary for different interferon formulations, changing brands may require a change in dosage. Therefore, physicians are cautioned not to change from one interferon product to another without considering these factors.

The physician should select patients for treatment with Alferon N Injection® after consideration of the locations and sizes of the lesions, response to previous treatment, and the patient's ability to comply with the treatment regimen. Data on Alferon N Injection® as initial treatment are limited. There are no data on a second course of Alferon N Injection® treatment. The mean number of warts treated in one treatment cycle was five.

Information for Patients --Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and should be advised to contact their physician if these symptoms occur.

Patients being treated with Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] should be informed of benefits and risks associated with treatment.

Patients should be cautioned not to change brands of interferon without medical consultation, as a change in dosage may occur.

Carcinogenesis, Mutagenesis, Impairment of Fertility --Studies with Alferon N Injection® have not been performed to determine carcinogenicity, mutagenicity, or the effect on fertility. In studies with adult females, interferon alpha has been shown to affect the menstrual cycle and decrease serum estradiol and progesterone levels5.

Alferon N Injection® should be used with caution in fertile men. Fertile women should be cautioned to use effective contraception while being treated with Alferon N Injection®.

Changes in the menstrual cycle and abortions have been reported to occur in non-human primates given extremely high doses of recombinant interferon alpha6. In these studies, Macaca mulatta (rhesus monkeys) were given interferon daily by intramuscular injection. When given at daily intramuscular doses 326 times the average intralesional dose of Alferon N Injection® (120 times the maximum recommended dose), this recombinant interferon formulation produced menstrual cycle changes in the monkeys.

In human clinical trials with Alferon N Injection®, menstrual cycle data were reported by 51 patients (36 Alferon N Injection® and 15 placebo). There was no significant difference between Alferon N Injection® and placebo treatment groups with regard to menstrual cycle changes.

PREGNANCY Pregnancy Category C --Animal reproduction studies have not been conducted with Alferon N Injection®. It is also not known whether Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Alferon N Injection® should be given to a pregnant woman only if clearly needed.

Changes in the menstrual cycle and abortions have been reported to occur in non-human primates given extremely high doses of recombinant interferon alpha. In these studies, Macaca mulatta (rhesus monkeys) were given interferon daily by intramuscular injection. Abortifacient effects were noted when the recombinant interferon alpha was given daily during early to mid-gestation at intramuscular doses of 978 times the average intralesional dose of Alferon N Injection® (360 times the maximum recommended dose).

Nursing Mothers --It is not known whether Alferon N Injection® is excreted in human milk. Studies in mice have shown that mouse interferons are excreted in milk7. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to not initiate drug treatment, taking into account the importance of the drug to the mother and the potential risks to the infant.

Pediatric Use --There have been no studies with this product in adolescents.

Page last updated: 2006-06-06

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