TM Owner ViiV Healthcare
Tivicay 50mg Tablet
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Indications & Clinical Uses
- Tivicay 50 mg tablets contain dolutegravir, an HIV integrase strand transfer inhibitor, used together with other antiretroviral medicines to treat HIV-1 infection in adults and children weighing at least 3 kg, from about 4 weeks of age for the lower-strength forms.
- The 50 mg once-daily tablet is used in treatment-naive adults and many treatment-experienced adults without documented or suspected resistance to integrase inhibitors; some treatment-experienced patients with such resistance take it twice daily.
- It can also be combined with rilpivirine alone as a two-drug complete regimen in adults who are already virologically suppressed.
- Tivicay is manufactured by ViiV Healthcare and is taken at home by the patient, with or without food, as a long-term daily treatment; it does not cure HIV.
Side Effects
- Tivicay does not carry a boxed warning.
- Common side effects, affecting up to about 1 in 30 people, include difficulty sleeping, headache, tiredness, dizziness, nausea and diarrhoea.
- Serious but less common reactions include hypersensitivity reactions with rash, fever, and sometimes liver or other organ problems, which require stopping Tivicay immediately and seeking urgent medical care, since continuing after such a reaction can be life-threatening.
- Liver problems can occur, especially in people with hepatitis B or C, so liver blood tests are monitored during treatment.
- Some people experience immune reconstitution inflammatory syndrome, where the recovering immune system reacts to old hidden infections, causing new or worsening symptoms in the weeks after starting treatment.
- Report any severe rash, yellowing of the skin or eyes, or unexplained fever promptly.
Precautions & Warnings
- Do not take Tivicay if you have ever had a hypersensitivity reaction to dolutegravir, or if you are taking dofetilide, which is contraindicated because dolutegravir raises dofetilide levels to a dangerous degree.
- Liver function is checked before and during treatment, particularly with hepatitis B or C co-infection.
- Watch for signs of immune reconstitution syndrome as your immune system recovers after starting therapy.
- Recent surveillance data show no clear increase in neural tube defects with dolutegravir use around conception, but discuss the current evidence and folic acid use with your healthcare provider if you are pregnant or planning pregnancy.
- Tivicay and the paediatric suspension Tivicay PD are not interchangeable milligram-for-milligram, so always use the exact product and dose your provider prescribes.
Avoid Interactions
- Tell your healthcare provider about every medicine and supplement you take.
- Never combine Tivicay with dofetilide.
- Antacids, laxatives, sucralfate, or supplements containing calcium, iron, magnesium or aluminium reduce dolutegravir absorption, so take Tivicay 2 hours before or 6 hours after these products.
- Carbamazepine, rifampin and certain other enzyme-inducing drugs lower dolutegravir levels and usually require the dose to be increased to twice daily; efavirenz, fosamprenavir/ritonavir and tipranavir/ritonavir have similar effects.
- Tivicay can raise metformin levels, so your metformin dose may need adjusting and blood sugar should be monitored more closely.
- There is no restriction on alcohol specific to Tivicay, but discuss any recreational drug use with your provider.
References
Frequently Asked Questions
Tivicay (dolutegravir) treats HIV-1 infection in adults and children from about 4 weeks old, always combined with other HIV medicines. The 50 mg tablet is usually taken once daily and can also pair with rilpivirine as a simple two-drug regimen in suppressed adults.
Take one Tivicay 50 mg tablet by mouth once daily, with or without food, at roughly the same time each day. Some people with resistance to integrase inhibitors take it twice daily instead. Never swap doses between Tivicay and Tivicay PD.
Common Tivicay side effects include trouble sleeping, headache, tiredness, dizziness, nausea and diarrhoea. Get urgent care for a severe rash, fever or swelling, which can signal a serious hypersensitivity reaction, and stop the tablet immediately if this happens.
Never take dofetilide with Tivicay (dolutegravir). Separate Tivicay from antacids, iron, calcium or magnesium supplements by 2 hours before or 6 hours after. Carbamazepine and rifampin can lower dolutegravir levels and may need a dose change to twice daily.
Take the missed Tivicay dose as soon as you remember that same day. If it is almost time for your next dose, skip the missed one and continue your normal schedule. Never double up, and keep taking it daily without gaps to avoid drug resistance.
Recent monitoring shows no clear rise in neural tube defects with dolutegravir taken around conception, but discuss folic acid and the latest evidence with your provider if pregnant or planning pregnancy. Tivicay is used in children from about 4 weeks of age at adjusted doses.
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