What Are the Pros and Cons of Interferon for Hepatitis C?

Recombinant human interferon 2b injection for indications for acute and chronic viral hepatitis (type B, type C, etc.), genital warts, hairy cell leukemia, chronic myelogenous leukemia, lymphoma, AIDS-related Kaposi's sarcoma, Treatment of malignant melanoma and other diseases.

Drug Name: Recombinant human interferon 2b injection

Drug type: Prescription drugs, medicines for medical workers' injuries
Use classification: Antitumor gene therapy drugs

Recombinant human interferon 2b injection components

The active ingredient of this product is recombinant human interferon 2b (produced by recombinant Pseudomonas carrying human leukocyte interferon 2b gene plasmid). The inactive ingredients are hydroxyethyl starch-40, sodium chloride, citric acid, and hydrogen phosphate. Disodium, mannitol, Tween-80. This product does not contain preservatives and blood extracts.

Characteristics of recombinant human interferon 2b injection

This product is a colorless transparent liquid with no insoluble matter visible to the naked eye.

Indications of recombinant human interferon 2b injection

For the treatment of acute and chronic viral hepatitis (type B, type C, etc.), genital warts, hair cell leukemia, chronic myelogenous leukemia, lymphoma, AIDS-related Kaposi's sarcoma, malignant melanoma and other diseases.

Recombinant human interferon 2b injection specifications

1ml: 1 million international units, 1ml: 3 million international units, 1ml: 5 million international units.

Usage and dosage of recombinant human interferon 2b injection

This product can be injected intramuscularly, subcutaneously and intralesionally.
1. Chronic Hepatitis B: The recommended dose is 3 to 5 million international units per injection, which is given once a day or every other day. The course is 3 to 6 months. The doctor can adjust the dose according to the specific conditions of the patient.
2. Chronic Hepatitis C: The recommended dose is 3 to 5 million international units per injection, which is given once a day or every other day. The course is 3 to 6 months. The doctor can adjust the dose according to the specific conditions of the patient.
3 Condyloma acuminatum: The recommended dose is 1 to 3 million international units per injection, three injections every other day every week, and a course of 1-2 months.
4 Hairy cell leukemia: The recommended dose is 3 million IU each time, and three injections every other day every week. The doctor can adjust the dose according to the specific situation of the patient. After 1 to 2 months of treatment, it usually shows curative effect. Intermittent treatment can be performed afterwards to make the condition relieve for a long time.
5. Chronic myelogenous leukemia: The recommended dose is 3-9 million international units per day for three months of treatment. Doctors can adjust the dose according to the specific conditions of the patient. Hemotherapy can be maintained after remission, and once every other day, the cytogenetic parameters can be relieved after 9-10 months.
6. Lymphoma (vesicular): The recommended dose is 3 million International Units, injected three times every other day-every week. According to the tolerability of different patients, the dose is increased weekly to the maximum tolerated amount (9 to 18 million international units) as appropriate, and the injection is performed three times every other day every week, and the course is 8-12 weeks. If no exacerbation or severe intolerance occurs, this dose should be continued for at least 12 months. Doctors can adjust the dosage according to the specific conditions of the patient, and at the same time, the phototherapy can improve the efficacy.
7. AIDS-related Kaposi's sarcoma: The recommended dose is 18 million International Units per day. If possible, the dose can be gradually increased to 36 million International Units. If there is no exacerbation or severe intolerance, this should be continued. therapy. When the response stabilized, the dose was changed to 18 million IU each time and injected three times every other day.
8. Malignant melanoma: The recommended dose is 9 to 18 million IUs each time. Three times every other week until the curative effect appears, and then continuous treatment. 18 million IUs each time. Three times every other week. Doctors can The situation and adjust the dose. After surgical resection of stage I and malignant melanoma, the adjuvant treatment with this product can reduce the recurrence rate.

Adverse reactions of recombinant human interferon 2b injection

Common adverse reactions when using this product are cold-like symptoms, such as fever, headache, chills, fatigue, muscle soreness, joint pain, etc. Some patients may experience anorexia, nausea, diarrhea, vomiting, leukopenia, thrombocytopenia, increased transaminase, and stop After the medicine can return to normal. Occasionally insomnia, rash, hair loss, increased or decreased blood pressure, tinnitus, decreased vision, nervous system dysfunction and so on.
Most of the adverse reactions are transient and reversible. They often appear in the first week of medication. Most of the adverse reactions disappear after 48 hours of exposure. If moderate to severe adverse reactions occur, you can consider adjusting the dosage or stopping the medication. Medication. Once an allergic reaction occurs, the medication should be stopped immediately.
References: Other adverse reactions reported in the literature on interferon alpha include: impaired consciousness, confusion, dizziness, dyskinesia, paresthesia, anxiety, depression, nervousness, lethargy, visual abnormality, transient rash, pruritus, and hearing loss; And rare seizures, restlessness, herpetic eruption, cold sores (non-herpetic), urticaria, stomatitis, bloating, hot flashes, autoimmune hepatitis, constipation, tachycardia, rhinitis, paralysis Intestinal colic, coagulopathy (prolonged prothrombin time and prothrombin-activated enzyme time), cough, thigh cramps. There are also rare suicidal tendencies, convulsions, coma, eye movement paralysis, orthostatic hypotension, pulmonary edema, heart failure, myocardial infarction, indigestion, flatulence, increased saliva, jaundice, ascites, ulcerative stomatitis, skin Erythema, purpura, sneezing, nasal congestion, interstitial pneumonia, dyspnea, thyroid dysfunction, hyperglycemia, hemolytic anemia, systemic lupus erythematosus, arthritis, decreased renal function, injection site reactions, and inflammation.

Restriction of recombinant human interferon 2b injection

1. In addition to recombinant human interferon 2b, this product also contains hydroxyethyl starch-40, sodium oxide, citric acid, disodium hydrogen phosphate, mannitol, and Tween-80. It does not contain preservatives and blood extraction ingredients. This product is contraindicated in patients with a history of allergies to any of the ingredients.
2. People with severe heart disease or autoimmune disease, epilepsy and impaired central nervous system function.
3 Severe liver, kidney or bone marrow dysfunction.
4 Those who have other serious diseases can not tolerate this product.

Precautions for recombinant human interferon 2b injection

1. This product is a colorless and transparent liquid. Do not use it if there are any abnormalities such as turbidity or precipitation, damage to the medicine bottle or pre-filled glass syringe, and expired medicine.
2. Pre-filled syringe injection method as directed by your doctor.
3 To avoid possible contamination, the inner packaging can be opened at the front. Any opened vials or pre-filled glass syringes should be discarded after the required dose of liquid is withdrawn or injected.
4 Use with caution by athletes.

Recombinant human interferon 2b injection for pregnant and lactating women

1. Pregnant women have limited medication experience, and methods for the safe use of this product during pregnancy have not been established. Therefore, when pregnant women need to use this product, it should be carefully considered by the clinician, and only when the benefit of the medication to the mother is greater than the potential danger to the fetus.
2. There is no data to show whether the interferon is secreted by breast milk after using this product. When lactating women need to take the drug, the importance of this product to the mother should be considered to decide whether to stop breastfeeding or stop using the drug.

Recombinant human interferon 2b injection for children

Children's experience with medication is still limited. In such cases, care should be taken to weigh the pros and cons and follow the doctor's advice.

Recombinant human interferon 2b injection for elderly medicine

For elderly patients with heart disease and advanced cancer, electrocardiogram should be performed before and during treatment of this product. Dosage adjustment or stop using this product according to the doctor's advice.

Drug interactions of recombinant human interferon 2b injection

Interferon may change the activity of some enzymes, especially reduce the activity of cytochrome enzyme P450, so the metabolism of drugs such as cimetidine, warfarin, theophylline, diazepam, and propranolol is affected. Interactions occur when combined with centrally acting drugs.

Recombinant human interferon 2b injection overdose

There have been no reports of drug overdose, but when used in large doses, there may be severe fatigue and weakness.

Pharmacology and toxicology of recombinant human interferon 2b injection

Pharmacology:
This product is produced by recombinant Pseudomonas carrying human leukocyte interferon 2b gene plasmid, and has broad-spectrum antiviral, antitumor, inhibiting cell proliferation, and improving immune functions. Interferon binds to cell surface receptors, induces cells to produce multiple antiviral proteins, and inhibits the virus from multiplying in the cell; interferon has a direct inhibitory effect on tumor cells, which can regulate the host's anti-tumor immune response and inhibit and decompose tumor cell growth The required factors and other effects change the relationship between the host and tumor cells; interferon improves immune functions including enhancing the phagocytosis of macrophages, enhancing the cytotoxicity of lymphocytes on target cells and the function of natural killer cells.
Toxicology:
Acute toxicity test: Intraperitoneal and intravenous injection of this product in mice, the doses are 150 million international units per kilogram and 150 million international units per kilogram, which are 105 and 104 times the human therapeutic amount. There were no symptoms of acute poisoning and no animals died.
Long-term toxicity test: intramuscular injection of this product in rats at a dose of 15 million international units per kilogram, 1.5 million international units per kilogram, and 150,000 international unit per kilogram, 5 times a week for a total of 6 months. General conditions of rats , Weight and behavior were not abnormal. The above test was repeated in rabbits, and no toxic reaction was seen in three months. The pathological tissue examination of rabbit internal organs did not reveal changes caused by the toxicity of this product.
Reproductive toxicity: The literature indicates that interferon may impair fertility. Abnormalities in the menstrual cycle of animals using interferon have been observed in primate studies. Women treated with human interleukin reported lower serum estradiol and progesterone concentrations. Therefore, women should not use this product unless they are using effective contraception during medication. Men of childbearing age should use this product with caution. Literature from foreign studies using rhesus monkeys shows that this product has an abortion effect at 90 to 180 times the recommended dose (2MIU / m ² ) for human muscle or subcutaneous injection. Although abortion occurred in each dose group (7.5MIU, 15MIU, and 30MIU / kg), compared with the control group, only in the medium and high dose groups (equivalent to the recommended dose of 2MIU / m ² 90 180 times) have statistical significance. High doses of other types of interferon alpha or beta are known to cause rhesus monkeys to produce dose-related ovulation cessation and abortion. This product is generally difficult to achieve the above toxic dose clinically.

Pharmacokinetics of recombinant human interferon 2b injection

This product is injected intramuscularly or subcutaneously. The peak time of blood concentration is 3.5-8 hours, and the elimination half-life is 4-12 hours. Kidney catabolism is the main elimination pathway of interferon, and elimination of bile secretion and liver metabolism is an important way. Intramuscular or subcutaneous absorption exceeds 80%.

Storage of recombinant human interferon 2b injection

Store and transport at 2-8 ° C, protected from light.

Packaging of recombinant human interferon 2b injection

Controlled glass bottles or prefilled glass syringes, 1 ml each.

Validity of recombinant human interferon 2b injection

24 months

Standard for Recombinant Human Interferon 2b Injection

"Chinese Pharmacopoeia" 2010 edition three and YBS01352006 ^[1]