Medicinal Products

AZATHIOPRINE MYLAN 50 mg

Generic drug of the therapeutic class: Immunology
active ingredients: Azathioprine
laboratory: Mylan

Divisible coated tablet
Box of 100
All forms

Indication

AZATHIOPRINE MYLAN 50 mg is indicated, in combination with other immunosuppressive drugs, in the prophylaxis of acute rejection of allogeneic kidney transplantation, liver, heart, lung, pancreas.

AZATHIOPRINE MYLAN 50 mg is usually indicated in immunosuppressive regimens as an adjunct to basic immunosuppressive agents.

AZATHIOPRINE MYLAN 50 mg is indicated in the following severe forms of the disease in patients with steroid or steroid-dependent intolerance or whose therapeutic response is insufficient despite treatment with high doses of steroids:

· Severe rheumatoid arthritis that can not be controlled by less toxic treatments,

· Severe or moderately severe chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis),

· Systemic lupus erythematosus,

· Dermatomyositis,

· Chronic active autoimmune hepatitis,

· Polyarteritis nodosa,

· Autoimmune haemolytic anemia refractory to treatment due to hot antibodies,

· Idiopathic thrombocytopenic purpura chronic refractory.

Dosage AZATHIOPRINE MYLAN 50 mg Breakable film-coated tablet Box of 100

Oral way.

Azathioprine tablets should be swallowed with a glass of water (200 ml minimum). They can be taken at mealtimes.

transplants

Depending on the immunosuppressive regimen adopted, an oral dosage of up to 5 mg / kg body weight / day maximum is usually given. The maintenance dose may vary between 1 and 4 mg / kg body weight / day and may be adjusted according to clinical requirements and haematological tolerance.

Other conditions

In general, the starting dose is between 1 and 3 mg / kg body weight / day and should be adjusted according to the clinical response (which may occur after several weeks or months) and hematological tolerance. For the treatment of progressive chronic hepatitis, the dose is usually between 1.0 and 1.5 mg / kg body weight / day. When a therapeutic result is evident, consideration should be given to lowering the maintenance dose to the lowest dose that is compatible with maintaining this result. If the patient's condition does not improve within three months to six months, discontinuation of this drug should be considered. The required maintenance dose may vary between 1 mg / kg body weight / day and 3 mg / kg body weight / day, depending on the pathology treated and the patient's individual response, as well as the hematological tolerance.

Use in patients with hepatic or renal insufficiency:

In patients with renal and / or hepatic impairment (mild to moderate insufficiency), doses administered should be within the lower range of normal limits. Azathioprine is contraindicated in severe hepatic and renal impairment (see section 4.3 ).

Use in children and adolescents:

Data are lacking to recommend the use of azathioprine for the treatment of juvenile idiopathic arthritis, systemic lupus erythematosus, dermatomyositis, and periarteritis nodosa (in children and adolescents under 18 years of age) .

For other indications, the dosage recommendations provided apply to children and adolescents as well as adults.

Use in the elderly:

No specific information is available on the safety of azathioprine in the elderly. It is recommended to use lower dose limits for adults and children (for haematological tests, see section 4.4. Special warnings and precautions for use ).

If concomitant administration of allopurinol, oxipurinol or thiopurinol with azathioprine, the dosage of azathioprine should be reduced to one-quarter of the original dose (see sections 4.4 Special warnings and precautions for use and Interactions with other drugs and other forms of interactions ).

The appearance of the therapeutic effect may take several weeks or months.

The drug can be given long-term unless the patient does not tolerate it.

In some diseases, rheumatoid arthritis or some hematological disorders for example, the treatment can be stopped without problem after a while.

Azathioprine should always be stopped gradually under close supervision.

Fraction of film-coated tablets should be avoided except to allow gradual shutdown. For correct long-term administration, the 25 mg strength should be used as needed (see sections 4.4 and special precautions for disposal and handling ).

Against indications

Hypersensitivity to azathioprine, 6-mercaptopurine (azathioprine metabolite) or to any of the excipients of the medicinal product.

· Severe infections

· Severe renal, hepatic or bone marrow impairment.

· Pancreatitis

· Any live vaccine is contraindicated in combination with azathioprine, especially BCG, yellow fever vaccine, smallpox vaccine.

· Pregnancy, unless the expected benefits outweigh the risks involved (see section Pregnancy and breastfeeding ).

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Azathioprine Mylan side effects

About 15% of patients are likely to experience side effects. The nature, frequency and severity of adverse reactions may depend on the dose of azathioprine and the duration of treatment, as well as the underlying disease of the patient and its associated treatments.

The main adverse effect attributed to azathioprine is a dose-dependent and generally reversible depression of bone marrow function, which manifests as leukopenia, thrombocytopenia and, in rare cases, anemia. Leukopenia can occur in more than 50% of patients receiving conventional doses of azathioprine. Other manifestations of bone marrow depression, namely thrombocytopenia, anemia, macrocytosis and megaloblastic abnormalities of the bone marrow, are less common.

The nature and frequency of the undesirable effects of azathioprine are summarized in the table below.

Very common

Frequent

Rare

Rare

Very rare

(≥1 / 10)

(≥1 / 100; <1/10)

(≥1 / 1000,

(≥1 / 10000,

(<1/10000),

<1/100)

<1/1000)

isolated cases

included

Infections and infestations

In 20% of patients who received renal homograft (HR).

Sensitivity to infections of patients with inflammatory bowel disease.

In <1% of patients with rheumatoid arthritis (RA).

Benign and malignant tumors (including cysts and polyps)

Up to 2.8% of HR patients (in decreasing order of frequency): Spinocellular carcinoma of the skin, non-Hodgkin's lymphoma, cervical cancer, Kaposi's sarcoma, vulvar cancer.

Lympho-proliferative disease post-transplantation.

Acute myeloid leukemia and myelodysplastic syndromes.

Blood and lymphatic system disorders

leukopenia

> 50% of HR patients (significant in 16% of cases),

- in 28% of patients with RA

- in 15% of patients with Crohn's disease.

Thrombocytopenia, anemia. Significant leukopenia in 5.3% of RA patients.

Granulocytopenia, pancytopenia and aplastic anemia, megaloblastic anemia, erythroid hypoplasia.

Immune system disorders

Hypersensitivity reactions with general malaise, hypotension, dizziness, leukocytosis, rash, severe nausea and vomiting, diarrhea, fever, chills, tremor, rash, myalgia, arthralgia, vasculitis, renal failure, elevated liver enzymes.

Hypersensitivity reactions of fatal evolution

Respiratory, thoracic and mediastinal disorders

Interstitial pneumonitis (reversible).

Gastrointestinal disorders

Nausea and anorexia with occasional vomiting (12% in RA).

Pancreatitis.

(0.2-8%, especially in transplant patients and patients with Crohn's disease).

Steatorrhea.

Diarrhea.

Peptic ulcer, gastrointestinal bleeding, necrosis or perforation. Colitis, diverticulitis. These complications are only observed after a transplant. The etiology is not known. Concomitant corticosteroid therapy may, however, play a role.

Hepatobiliary disorders

Hepatic insufficiency. Various pathologies: cholestasis, destructive cholangitis, peliosis hepatis, fibrosis of Disse spaces and nodular regenerative hyperplasia in 3-10% of patients after HR.

Hepatotoxicity is seen in <1% of patients with RA.

Hepatic veno-occlusive disease threatening the life.

Skin and subcutaneous tissue disorders

Alopecia.

Immune system disorders

In the event of a hypersensitivity reaction, the immediate discontinuation of azathioprine and the possible introduction of circulatory assistance have resulted in recovery in most cases. Azathioprine should not be restarted after a hypersensitivity reaction to the product.

Blood and lymphatic system disorders

The predisposing disorders to bone marrow toxicity of azathioprine are TPMT deficiency, hepatic insufficiency and renal failure.

Although adverse effects on hematopoiesis occur primarily at the beginning of azathioprine treatment, their late onset has also been reported. Careful control of the number of blood cells is therefore recommended, even in patients receiving long-term stable therapy (see section 4.4 ).

Gastrointestinal disorders

It is possible to reduce gastrointestinal disturbances by administering azathioprine several times and / or during meals.

It should be remembered that azathioprine may induce exacerbation of diarrhea in patients with chronic inflammatory bowel disease.

Hepatobiliary disorders

A rare, but life-threatening, veno-occlusive liver disease has been described during chronic azathioprine therapy, primarily in transplant patients. In isolated cases, discontinuation of azathioprine resulted in temporary or definitive normalization of histology and hepatic symptoms.

Cholestasis and liver function degradation are usually reversible on discontinuation of azathioprine.

Benign and malignant tumors

An increased risk of developing a tumor exists when used after transplantation and in other indications. However, doses are usually higher for transplant-related indications. The risk of developing a tumor is therefore greater in a transplant context than in other indications. The type of tumor, however, does not differ according to the indications. Tumors typically occur in a context of immunosuppression (induced by oncovirus or natural irradiation).

Skin and subcutaneous tissue disorders

Hair loss has been described on a number of occasions in patients receiving azathioprine and other immunosuppressive agents. In many cases, the problem was solved spontaneously without interrupting the treatment.

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