Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The following adverse reactions have been reported during therapy for HIV disease with Epivir.

The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood and lymphatic systems disorders
Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia

Metabolism and nutrition disorders
Very rare: Lactic acidosis

Nervous system disorders
Common: Headache, insomnia
Very rare: Peripheral neuropathy (or paraesthesia)
Respiratory, Thoracic and mediastinal disorders
Common: Cough, nasal symptoms

Gastrointestinal disorders
Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea
Rare: Pancreatitis, elevations in serum amylase

Hepatobiliary disorders
Uncommon: Transient elevations in liver enzymes (AST, ALT)
Rare: Hepatitis
Skin and subcutaneous tissue disorders
Common: Rash, alopecia
Rare: Angioedema

Musculoskeletal and connective tissue disorders
Common: Arthralgia, muscle disorders
Rare: Rhabdomyolysis

General disorders and administration site conditions
Common: Fatigue, malaise, fever

Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)

In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).

Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). The frequency of which is unknown (see section 4.4).

Paediatric population

1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1). No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
Additionally, you should also report to GSK Israel (il.safety@gsk.com)