Patient Leaflet Updated 21-Oct-2024 | Merck Sharp & Dohme (UK) Limited
Delstrigo 100 mg/300 mg/245 mg film-coated tablets
Delstrigo® 100 mg/300 mg/245 mg film-coated tablets
doravirine/ lamivudine/ tenofovir disoproxil
1. What Delstrigo is and what it is used for
2. What you need to know before you take Delstrigo
3. How to take Delstrigo
4. Possible side effects
5. How to store Delstrigo
6. Contents of the pack and other information
Delstrigo is used to treat HIV (‘human immunodeficiency virus’) infection. It belongs to a group of medicines called ‘antiretroviral medicines’.
Delstrigo contains the active substances:
Delstrigo is used to treat HIV infection in adults and adolescents aged 12 years and older weighing at least 35 kg. HIV is the virus that causes AIDS (‘acquired immune deficiency syndrome’). You should not take Delstrigo if your doctor has told you that the virus causing your infection is resistant to any of the medicines in Delstrigo.
Delstrigo works by preventing HIV from making more viruses in your body. This will help by:
Do not take Delstrigo if the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Delstrigo. See also the list in section “Other Medicines and Delstrigo”.
Talk to your doctor, pharmacist, or nurse before taking Delstrigo.
If you have both HIV and hepatitis B virus infections, your hepatitis B may get worse if you stop taking Delstrigo. You may require blood tests for several months after stopping treatment. Discuss your hepatitis B therapy with your doctor.
This can happen in some people who take Delstrigo. Your doctor will do blood tests to check your kidney function before and during treatment with Delstrigo.
This can happen in some people who take Delstrigo. Bone problems include bone pain, and bone softening or thinning (which may lead to fractures). Joint or muscle pain or muscle weakness may also occur. Your doctor may need to do additional tests to check your bones.
This can happen when you start taking any HIV medicine, including Delstrigo. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV medicine.
Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice 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, please inform your doctor immediately to seek necessary treatment.
Do not give this medicine to children aged less than 12 years or weighing less than 35 kg. The use of Delstrigo in children aged less than 12 years or weighing less than 35 kg has not yet been studied.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because other medicines may affect how Delstrigo works, and Delstrigo might affect the way some other medicines work.
There are some medicines you must not take with Delstrigo. See list under “Do not take Delstrigo” section.
Talk to your doctor before taking the following medicines with Delstrigo as your doctor may need to change the dose of your medicines:
If your doctor decides you should take these medicines with Delstrigo, your doctor will prescribe a 100 mg tablet of doravirine to be taken daily, approximately 12 hours after your dose of Delstrigo.
Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Delstrigo:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Delstrigo. It is preferable to avoid the use of Delstrigo during pregnancy. This is because it has not been studied in pregnancy and it is not known if Delstrigo will harm your baby while you are pregnant.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Use with caution when driving, riding a bicycle, or operating machines if you feel tired, dizzy, or sleepy after taking this medicine
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure. Delstrigo is a complete regimen taken as a single tablet for the treatment of HIV infection.
The recommended dose is 1 tablet once a day. If you take certain medicines your doctor may need to change the amount of doravirine you take. See “Other medicines and Delstrigo” section for a list of medicines.
Do not take more than the recommended dose. If you accidentally take more, contact your doctor.
Do not run out of Delstrigo. Refill your prescription or talk to your doctor before your Delstrigo is all gone.
If you stop taking Delstrigo, your doctor will need to check your health often and do blood tests regularly for several months to check your HIV infection. If you have HIV infection and hepatitis B infection, it is especially important not to stop your Delstrigo treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has worsened after stopping lamivudine or tenofovir disoproxil (two of the three active substances of Delstrigo). If Delstrigo is stopped your doctor may recommend that you resume hepatitis B treatment. You may need blood tests to check how your liver is working for 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not stop taking this medicine without first talking to your doctor.
Common: may affect up to 1 in 10 people:
Blood tests may also show:
Uncommon: may affect up to 1 in 100 people:
Blood tests may also show:
The muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Rare: may affect up to 1 in 1,000 people:
Blood tests may also show:
Very rare: may affect up to 1 in 10,000 people:
Blood tests may also show:
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Delstrigo is available as a yellow, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 776 on one side and plain on the other side.
The following pack sizes are available:
Not all pack sizes may be available in your country.
Marketing Authorisation Holder:
Manufacturer:
Other sources of information
For any information about this medicine, please contact:
This leaflet was last revised in August 2024
© 2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
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