Interal-P (Lyophilisate) Instructions for Use

Marketing Authorization Holder

State Research Institute Of Occupational Health (Russia)

ATC Code

L03AB05 (Interferon alfa-2b)

Active Substance

Interferon alfa-2b

Interferon alfa-2b (USAN)

Dosage Forms

	Interal-P	Lyophilisate for preparation of solution for injections 1 million IU: amp. 5 pcs.
		Lyophilisate for preparation of solution for injections 3 million IU: amp. 5 or 10 pcs.
		Lyophilisate for preparation of solution for injections 5 million IU: amp. 5 or 10 pcs.
		Lyophilisate for preparation of solution for injections 500 thousand IU: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Stabilizer human donor albumin up to 5 mg/ml.

500000 IU – ampoules (5) – contour packages (1) – cardboard packs.

Stabilizer human donor albumin up to 5 mg/ml.

1000000 IU – ampoules (5) – contour packages (1) – cardboard packs.

Stabilizer human donor albumin up to 5 mg/ml.

3000000 IU – ampoules (5) – contour packages (1) – cardboard packs.

Stabilizer human donor albumin up to 5 mg/ml.

5000000 IU – ampoules (5) – contour packages (1) – cardboard packs.

Clinical-Pharmacological Group

Interferon. Antitumor, antiviral, and immunomodulatory drug

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

Interal-P possesses antiviral, antitumor, and immunomodulatory activity.

When administered parenterally, it undergoes breakdown and is partially excreted unchanged, mainly through the kidneys.

The drug, like all interferons, can lead to the appearance of specific antibodies, which leads to a decrease in its therapeutic effect.

Indications

In complex therapy in adults

• For acute viral hepatitis B – moderate and severe forms at the beginning of the icteric period up to the 5th day of jaundice (at later dates, the prescription of the drug is less effective, Interal-P is not effective in developing hepatic coma and cholestatic course of the disease);
• For acute protracted hepatitis B, chronic active hepatitis B and D without signs of cirrhosis and at the initial stage of liver cirrhosis;
• For chronic active hepatitis C, accompanied by the determination of antibodies to the hepatitis C virus, high viral load according to polymerase chain reaction, increased ALT activity without signs of hepatic decompensation (Child-Pugh class A). For the treatment of chronic viral hepatitis C, monotherapy or combination therapy with ribavirin is recommended in the absence of contraindications. The duration of treatment and optimal drug doses are determined by the attending physician depending on the tolerability of therapy and its results;
• For viral (influenza, adenoviral, enteroviral, herpetic, mumps), viral-bacterial and mycoplasmal meningoencephalitis. The use of Interal-P is most effective in the first 4 days of the disease;
• For stromal keratitis and keratoiridocyclitis;
• For stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (mycosis fungoides, primary reticulosis), Kaposi’s sarcoma, basal cell and squamous cell skin cancers, keratoacanthoma, chronic myeloid leukemia, histiocytosis-X, subleukemic myelosis, essential thrombocytopenia;
• For multiple sclerosis.

In complex therapy in children

• For acute lymphoblastic leukemia in the remission period after the end of inductive chemotherapy (at 4-5 months of remission);
• For respiratory papillomatosis of the larynx, starting from the next day after papilloma removal;
• For chronic active hepatitis C in children, starting from three years of age, in monotherapy and in combination therapy with antiviral drugs.

ICD codes

Dosage Regimen

Interal-P is administered intramuscularly, into the lesion or under the lesion, subconjunctivally.

Immediately before use, the contents of the ampoule are dissolved in water for injections (1 ml for intramuscular administration and administration into the lesion, 5 ml for subconjunctival administration).

The dissolution time is no more than 3 minutes. The drug solution should be transparent, without foreign inclusions. The diluted drug must not be stored.

Intramuscular administration. For acute hepatitis B, Interal-P is administered at 1 million IU 2 times a day for 5-6 days, then the dose is reduced to 1 million IU per day and administered for another 5 days.

If necessary (after control biochemical blood tests), the course of treatment can be continued at 1 million IU 2 times a week for 2 weeks. The course dose is 15-21 million IU.

For acute protracted and chronic active hepatitis B with exclusion of delta infection and without signs of liver cirrhosis, Interal-P is administered at 1 million IU 2 times a week for 1-2 months.

In the absence of effect, treatment is extended to 3-6 months or after the end of 1-2 months of treatment, 2-3 similar courses are conducted with an interval of 1-6 months.

For chronic active hepatitis D without signs of liver cirrhosis, the drug is administered at 500 thousand-1 million IU per day 2 times a week for 1 month.

A repeated course of treatment after 1-6 months.

For chronic active hepatitis B and D with signs of liver cirrhosis, at 250-500 thousand IU per day 2 times a week for 1 month.

If signs of decompensation appear, similar repeated courses are conducted with an interval of at least 2 months.

For chronic hepatitis C, monotherapy with Interal-P subcutaneously at 3 million IU once a day every other day for 24 weeks or combination therapy with ribavirin is recommended.

In case of disease relapse after a course of interferon monotherapy, a repeated course must be conducted in combination with ribavirin for at least 6 months.

In patients in whom hepatitis C virus RNA (HCV RNA) is not detected in the blood serum by the end of the first 6 months of therapy, treatment is continued for another 6 months.

For chronic hepatitis C in children, monotherapy (excluding treatment of patients with virus genotype 1b) at 3 million IU/m² of body surface area, but not more than 3 million IU, 3 times a week or combination therapy with antiviral drugs for 12 months is recommended.

In the absence of an early virological response during monotherapy (after 3 months), it is necessary to switch to combination therapy.

For kidney cancer, Interal-P is used at 3 million IU daily for 10 days.

Repeated courses of treatment (3-9 or more) are conducted at intervals of 3 weeks. The total amount of the drug is from 120 million IU to 300 million IU or more.

For hairy cell leukemia, Interal-P is administered daily at 3-6 million IU for 2 months.

After normalization of the hemogram, the daily dose of Interal-P is reduced to 1-2 million IU.

Then maintenance therapy is prescribed at 3 million IU 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million IU or more.

For acute lymphoblastic leukemia in children in the remission period after the end of inductive chemotherapy (at 4-5 months of remission) at 1 million IU once a week for 6 months, then once every 2 weeks for 24 months.

Maintenance chemotherapy is conducted simultaneously.

For chronic myeloid leukemia at 3 million IU daily or 6 million IU every other day.

The treatment period is from 10 weeks to 6 months.

For histiocytosis-X – at 3 million IU daily for 1 month.

Repeated courses with 1-2-month intervals for 1-3 years.

For subleukemic myelosis and essential thrombocytopenia to correct hyperthrombocytosis at 1 million IU daily or every other day for 20 days.

For malignant lymphomas and Kaposi’s sarcoma, Interal-P is administered at 3 million IU per day daily for 10 days in combination with cytostatics (prospidin, cyclophosphan) and glucocorticosteroids.

For tumor stage of mycosis fungoides and reticulosarcomatosis, it is advisable to alternate intramuscular administration of Interal-P at 3 million IU and intralesional administration at 2 million IU for 10 days.

In patients with erythrodermic stage of mycosis fungoides with an increase in temperature above 39°C (102.2°F) and in case of exacerbation of the process, the administration of the drug should be discontinued.

With insufficient therapeutic effect after 10-14 days, a repeated course of treatment is prescribed.

After achieving a clinical effect, maintenance therapy is prescribed at 3 million IU once a week for 6-7 weeks.

For respiratory papillomatosis of the larynx, the drug is administered at 100-150 thousand IU per 1 kg of body weight daily for 45-50 days, then at the same dosage 3 times a week for 1 month.

The second and third courses are conducted at intervals of 2-6 months.

For multiple sclerosis, Interal-P is prescribed at 1 million IU: for pyramidal syndrome – 3 times a day, for cerebellar syndrome – 1-2 times a day for 10 days with subsequent administration of 1 million IU once a week for 5-6 months.

The total amount of the drug is 50-60 million IU.

In individuals with a high pyrogenic reaction (39°C (102.2°F) and above) to the administration of Interal-P, simultaneous use of indomethacin is recommended.

Perifocal administration. For basal cell and squamous cell cancer, keratoacanthoma, Interal-P is administered under the lesion at 1 million IU once a day daily for 10 days.

In case of pronounced local inflammatory reactions, administration under the lesion is carried out every 1-2 days.

After the end of the course, if necessary, cryodestruction is performed.

Subconjunctival administration. For stromal keratitis and keratoiridocyclitis, subconjunctival injections of Interal-P are prescribed at a dose of 60 thousand IU in a volume of 0.5 ml daily or every other day depending on the severity of the process.

Injections are performed under local anesthesia with a 0.5% dicaine solution.

The course of treatment is from 15 to 25 injections.

Adverse Reactions

With parenteral administration of the drug Interal-P, chills, fever, fatigue, skin rashes and itching, as well as leuko- and thrombocytopenia are possible; in the case of the latter, it is necessary to perform a blood test 2-3 times a week.

When injecting the lesion – a local inflammatory reaction.

These side effects usually are not an obstacle to continuing the use of Interal-P.

With sharply pronounced local and general side reactions, the administration of Interal-P should be discontinued.

Contraindications

• Severe forms of allergic diseases;
• Pregnancy.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Pediatric Use

Prescribed to children according to indications.

Drug Interactions

Not identified.

Storage Conditions

List B. At a temperature from 2 to 10°C (50°F), in accordance with SP 3.3.2.1248-03.

Store in places inaccessible to children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.