| Note
: For
the use of registered medical practitioner, hospital
or laboratory only |
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| INTALFA - Information
for Professionals: |
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| DOSAGE
AND ADMINISTRATION |
Chronic Myelogenous
Leukemia:
The recommended dose of interferon alfa-2b is 4 to 5 million IU/m2 administered
daily subcutaneously. When white cell count is controlled, the dosage may be
administered three times a week. The dosage may be adjusted according to patient’s
tolerance to the medicine. |
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Chronic Hepatitis
C:
The recommended dosage of interferon alfa-2b, recombinant for injection for the
treatment of chronic hepatitis C is 3 million IU three times a week (tiw) administered
subcutaneously or intramuscularly. Patients who do not normalize their
ALTs after 16 weeks of therapy rarely achieve a sustained response with extension
of treatment. Consideration should be given to discontinuing these patients from
therapy. |
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Chronic Hepatitis
B: Adults:
The recommended dosage of interferon alfa-2b, recombinant for injection for the
treatment of chronic hepatitis B is 30-35 million IU per week, administered subcutaneously
or intramuscularly, either as 5 million IU daily (qd) or as 10 million IU 3 times
a week (tiw) for 16 weeks. |
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| CONTRAINDICATIONS |
| Interferon
alfa-2b, recombinant for injection is contraindicated
in-patients with a history of hypersensitivity to interferon
alfa or any component of the injection. |
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| WARNINGS |
General
Because of the fever and other "flu-like" symptoms associated with
interferon alfa-2b administration, it should be used cautiously in patients with
debilitating medical conditions, such as those with a history of pulmonary disease
(e.g., chronic obstructive pulmonary disease), or diabetes mellitus prone
to ketoacidosis. Caution should also be observed in patients with coagulation
disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Patients with platelet counts of less than 50,000/mm3 should not be administered
interferon alfa-2b. |
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| Interferon alfa-2b,
recombinant therapy should be used cautiously in patients
with a history of cardiovascular disease. Patients with
a preexisting psychiatric condition, especially depression,
or a history of severe psychiatric disorder should not
be treated with interferon alfa-2b. Patients with preexisting
thyroid abnormalities whose thyroid function cannot be
maintained in the normal range by medication should not
be treated with interferon alfa-2b. Any patient developing
liver function abnormalities during treatment should be
monitored closely and if appropriate, treatment should
be discontinued. |
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| Any patient developing
an autoimmune disorder during treatment should be closely
monitored and, if appropriate, treatment should be discontinued.
There may be synergistic adverse effects between interferon
alfa-2b and zidovudine. Patients receiving concomitant
zidovudine have had a higher incidence of neutropenia than
that expected with zidovudine alone. Careful monitoring
of the WBC count is indicated in all patients who are myelosuppressed
and in all patients receiving other myelosuppressive medications. |
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| Patients with decompensated
liver disease, autoimmune hepatitis or a history of autoimmune
disease, and patients who are immunosuppressed transplant
recipients should not be treated with interferon alfa-2b. |
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| PRECAUTIONS: |
General:
The drug should be discontinued immediately and appropriate medical therapy instituted
in case of acute serious hypersensitivity reactions. |
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Laboratory
Tests:
The following laboratory tests are recommended for all patients on interferon
alfa-2b therapy, prior to beginning treatment and then periodically thereafter.
Hemoglobin, complete and differential white blood cell counts, and platelet count. |
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Blood Chemistry:
Electrolytes, liver function tests, and TSH. Those patients who have preexisting
cardiac abnormalities and/or are in advanced stages of cancer should have electrocardiograms
taken prior to and during the course of treatment. Carcinogenesis, Mutagenesis,
and Impairment of Fertility: Studies with interferon alfa-2b, had not been
performed to determine carcinogenicity. Interferon may impair fertility. Therefore,
fertile women should not receive interferon alfa-2b, unless they are using
effective contraception during the therapy period. Interferon alfa-2b should
be used with caution in fertile men. Mutagenicity studies have demonstrated
that interferon alfa-2b is not mutagenic. |
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Pregnancy Category
C:
Interferon alfa-2b, should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. |
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Nursing Mothers:
Because of the potential for serious adverse reactions from the drug in nursing
infants, a decision should be made whether to discontinue nursing or to discontinue
interferon alfa-2b, taking into account the importance of the drug to the mother. |
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Pediatric Use:
Safety and effectiveness in pediatric patients below
the age of 18 years have not been established. |
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| DRUG
INTERACTIONS: |
| Interactions
between interferon alfa-2b, recombinant for injection
and other drugs have not been fully evaluated. Caution
should be exercised when administering interferon alfa-2b,
in combination with other potentially myelosuppressive
agents such as zidovudine. Concomitant use of alfa interferon
and theophylline decreases theophylline clearance resulting
in a 100% increase in serum theophylline levels. |
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| ADVERSE REACTIONS: |
| The most frequently
reported adverse reactions were "flu-like" symptoms,
particularly fever, headache, chills, myalgia, and fatigue.
Less common adverse effects include vomiting, dry mouth,
taste alteration, dizziness, confusion, hypotension, and
increased sweating. Rarely reported adverse effects include
rash, abdominal pain, epistaxis, hypertension, tachycardia,
gingival bleeding and decreased libido. More severe toxicities
are observed generally at higher doses and may be difficult
for patients to tolerate. In addition, the following spontaneous
adverse experiences have been reported during the marketing
surveillance of interferon alfa-2b, recombinant for injection:
nephrotic syndrome, pancreatitis, renal failure, and renal
insufficiency. Interferon alfa-2b used alone or in combination
with ribavirin may be associated with aplastic anemia.
Rarely, sarcoidosis or exacerbation of sarcoidosis has
been reported. |
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| HOW SUPPLIED: |
| INTALFA (recombinant
Human Interferon Alfa 2b) is available in 1 ml prefilled
syringes containing 3 MIU or 5 MIU Recombinant Interferon
Alfa 2b. |
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| Storage: |
| Store between 2-8°C
(36-46°F). Do not freeze. |
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For
further details and product specifications please contact
us. |
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