Medicinal Products

ABACAVIR / LAMIVUDINE MYLAN PHARMA 600 mg / 300 mg

Generic drug from Kivexa
Therapeutic class: Infectiology - Parasitology
active ingredients: Abacavir + Lamivudine
laboratory: Mylan

Coated tablet
box of 30
All forms

Indication

ABACAVIR / LAMIVUDINE MYLAN PHARMA is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see Warnings and Precautions for Use section). and pharmacodynamic properties ).

Before beginning treatment with abacavir, HLA-B * 5701 should be screened for any HIV-infected patient, regardless of their race (see Warnings and Precautions section). ). Abacavir should not be used in patients with the HLA-B * 5701 allele.

Dosage ABACAVIR / LAMIVUDINE MYLAN PHARMA 600 mg / 300 mg film-coated tablet box of 30

ABACAVIR / LAMIVUDINE MYLAN PHARMA is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see Warnings and Precautions for Use section). and pharmacodynamic properties ).

Before beginning treatment with abacavir, HLA-B * 5701 should be screened for any HIV-infected patient, regardless of their race (see Warnings and Precautions section). ). Abacavir should not be used in patients with the HLA-B * 5701 allele.

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition . See Warnings and Precautions and Adverse Reactions sections.

Adverse effects Abacavir / lamivudine Mylan Phar

Summary of the security profile

Adverse reactions reported with abacavir / lamivudine are consistent with known safety profiles for abacavir and lamivudine when administered separately. For most of these adverse effects, the causality study could not formally determine the respective responsibilities of the active substances, the many concurrent treatments, and the HIV infection.

Most of the effects listed in the following table occur frequently (nausea, vomiting, diarrhea, fever, lethargy, rash) in patients with abacavir hypersensitivity reactions. Therefore, in patients with any of these symptoms, the presence of a hypersensitivity reaction should be carefully investigated (see Warnings and Precautions ). Cases of erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome, for which the hypothesis of a hypersensitivity reaction to abacavir could not be ruled out, have been very rarely reported. In these cases, medicines containing abacavir must be permanently discontinued.

Summary table of adverse effects

Adverse reactions considered to be related to abacavir or lamivudine are listed below by organ class and absolute frequency. The frequencies are defined according to the following categories: very frequent (> 1/10), frequent (1/100), uncommon (1/1000), rare (1/10 000) and very rare (<1/10 000) .

Body class

abacavir

lamivudine

Blood and lymphatic system disorders

Uncommon : neutropenia and anemia (both sometimes severe), thrombocytopenia

Very rare: erythroblastopenia

Immune system disorders

Common: hypersensitivity reaction

Metabolism and nutrition disorders

Frequent: anorexia

Very rare : lactic acidosis

Very rare : lactic acidosis

Nervous system disorders

Common: headache

Common : headache, insomnia

Very rare: cases of peripheral neuropathy (or paresthesia) have been reported

Respiratory, thoracic and mediastinal disorders

Common: cough, nasal symptomatology

Gastrointestinal disorders

Frequent : nausea, vomiting, diarrhea

Rare : pancreatitis reported but causal relationship to abacavir treatment is uncertain

Common: nausea, vomiting, abdominal pain or cramps, diarrhea

Rare : elevation of serum amylase. Cases of pancreatitis have been reported

Hepatobiliary disorders

Uncommon: transient elevation of liver enzymes (ASAT, ALAT)

Rare: hepatitis

Skin and subcutaneous tissue disorders

Common: rash (no systemic symptoms)

Very rare: erythema multiforme, Stevens-Johnson syndrome and Lyell's syndrome

Common: rash, alopecia

Rare : angioedema

Musculoskeletal and systemic disorders

Common: arthralgia, muscle disorders

Rare: rhabdomyolysis

General disorders and administration site conditions

Frequent: fever, lethargy, fatigue

Frequent: tiredness, malaise, fever

Description of some adverse effects

Hypersensitivity to abacavir

The signs and symptoms associated with a hypersensitivity reaction to abacavir are listed below.

These have been identified during clinical trials or post-marketing follow-up. Adverse reactions reported in at least 10% of patients with a hypersensitivity reaction appear in bold.

In almost all patients with a hypersensitivity reaction, the syndrome has fever and / or rash (usually maculopapular or urticarial), however some patients have had a reaction without fever or rash.

Other symptoms suggestive of hypersensitivity include gastrointestinal, respiratory or general symptoms such as lethargy and malaise.

Skin and subcutaneous tissue disorders

Rash (usually maculopapular or urticarial)

Gastrointestinal disorders

Nausea, vomiting, diarrhea, abdominal pain, mouth ulcers

Respiratory, thoracic and mediastinal disorders

Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure

Various effects

Fever, lethargy, malaise, edema, lymphadenopathy, low blood pressure, conjunctivitis, anaphylaxis

Nervous system disorders / Psychiatric disorders

Headache, paresthesia

Blood and lymphatic system disorders

lymphopenia

Hepatobiliary disorders

Hepatic dysfunction, hepatitis, liver failure

Musculoskeletal and systemic disorders

Myalgia, rarely rhabdomyolysis, arthralgia, elevation of creatine phosphokinase

Renal and urinary disorders

Elevation of creatinine, renal insufficiency

Symptoms related to this hypersensitivity reaction worsen with continued treatment and may be life-threatening; in rare cases they have been fatal.

Resumption of abacavir therapy after a hypersensitivity reaction results in a rapid reappearance of symptoms within a few hours. This recurrence is usually more severe than the initial episode and can lead to life-threatening hypotension and lead to death. In rare cases, similar reactions have also occurred in patients who have restarted abacavir therapy, despite having experienced only one of the symptoms suggestive of a hypersensitivity reaction (see above). prior to stopping treatment with abacavir; very rarely reactions have also been observed in patients for whom treatment was reintroduced when they did not previously show any symptoms of hypersensitivity (that is, patients previously considered to be abacavir-tolerant).

Metabolic parameters

Increased body weight, blood lipid and glucose levels may occur during antiretroviral therapy (see Warnings and Precautions section ).

Immune restoration syndrome

In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory response to asymptomatic or residual opportunistic infections may occur. Cases of autoimmune disorders (such as Graves' disease) have also been reported in a context of immune restoration; however, the reported onset time varies more, and these events may occur several months after initiation of treatment (see Warnings and Precautions ).

osteonecrosis

Cases of osteonecrosis have been reported, particularly in patients with known risk factors, advanced HIV-related disease, or combination therapy with long-term antiretrovirals. Their frequency of occurrence is not known (see section Warnings and Precautions ).

Pediatric population

The safety data supporting the once-daily dosing regimen in children are from the ARROW study (COL105677) in which 669 pediatric patients (aged 12 months to 17 years) infected with HIV-1 received abacavir and lamivudine in one or two daily doses (see section 5.1 Pharmacodynamic properties ). In this population, 104 pediatric patients infected with HIV-1 and weighing at least 25 kg received abacavir and lamivudine as a tablet once daily. No new safety concerns have been identified in pediatric patients receiving the recommended dosage, either once or twice daily, compared to adult patients.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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