Tenovid

Tenovid Special Precautions

tenofovir disoproxil fumarate

Manufacturer:

Samjin

Distributor:

SB Pharma
Full Prescribing Info
Special Precautions
Patients must be advised before taking Tenovid.
Patients should take care not to infect other people. HIV can still be passed when taking this medicine, although the risk is lowered by effective antiretroviral therapy. The precautions needed should be discussed to avoid infecting other people. Tenovid does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. The patient must continue to take precautions to avoid this.
Advise the patient to inform the doctor or pharmacist if the patient has had kidney disease or if tests have shown problems with the kidneys. Tenovid should not be given to adolescents with existing kidney problems. Before starting treatment, blood tests may be ordered to assess the kidney function. Tenovid may affect the kidneys during treatment. Blood tests may be ordered during treatment to monitor how the kidneys work. If the patient is an adult, the patient may be advised to take the tablets less often. Advise the patient not to reduce the prescribed dose, unless the doctor has told the patient to do so. Tenovid is not usually taken with other medicines that can damage the kidneys (see Interactions). If this is unavoidable, the kidney function should be monitored once a week.
Bone problems: Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. Advise the patient to inform the doctor in case of any of these symptoms.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see Side Effects). Advise the patient to inform the doctor if the patient has bone pain or fractures.
Tenofovir disoproxil fumarate may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil fumarate in combination with a boosted protease inhibitor.
Overall, the effects of tenofovir disoproxil fumarate on long term bone health and future fracture risk in adult and paediatric patients are uncertain. Advise the patient to inform the doctor if the patient is suffering from osteoporosis. Patients with osteoporosis are at a higher risk for fractures.
Advise the patient to talk to the doctor if the patient has a history of liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If the patient has hepatitis B infection, the best treatment should be carefully considered for the patient. If the patient has a history of liver disease or chronic hepatitis B infection, blood tests may be conducted to monitor the liver function.
Look out for infections. If the patient has advanced HIV infection (AIDS) and has an infection, symptoms of infection and inflammation may be developed or symptoms of an existing infection may be worsened once treatment with Tenovid is started. These symptoms may indicate that the body's improved immune system is fighting infection. Look out for signs of inflammation or infection soon after the patient starts taking Tenovid. Advise the patient to inform the doctor at once in case of signs of inflammation or infection.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after the patient starts taking medicines for the treatment of their HIV infection. Autoimmune disorders may occur many months after the start of treatment. Patients must be advised to seek medical attention immediately in case of any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity.
Advise the patient to talk to the doctor or pharmacist if the patient is over 65. Tenovid has not been studied in patients over 65 years of age. If the patient is older than this and is prescribed Tenovid, the patient should be carefully monitored.
Tenovid contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving and using machines: Tenovid can cause dizziness. If the patient feels dizzy while taking Tenovid, the patient should not drive or ride a bicycle and use any tools or machines.
Use in Children: Tenovid tablets 300 mg are suitable for: HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Tenovid tablets 300 mg are not suitable for the following groups: Not for HIV-1 infected children under 12 years of age.
Not for HBV infected children under 12 years of age.
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