WARNING

Dovato is a medication used to treat HIV-1 infection. While it can be effective in managing the virus, there are potential risks associated with taking it. Some common risks include:

• Drug Interactions: Dovato may interact with other medications, potentially reducing their effectiveness or causing harmful side effects.
• Allergic Reactions: Some individuals may experience allergic reactions to Dovato, which can range from mild to severe and require immediate medical attention.
• Liver Problems: Dovato can cause liver problems, including liver enlargement, which may lead to symptoms such as jaundice (yellowing of the skin or eyes), dark urine, or abdominal pain.
• Immune Reconstitution Syndrome (IRS): After starting Dovato, some patients may experience inflammatory reactions from previously acquired infections, which can cause symptoms such as fever, swollen lymph nodes, or worsening of pre-existing infections.
• Lactic Acidosis: In rare cases, Dovato may lead to a condition called lactic acidosis, characterized by an excess buildup of lactic acid in the bloodstream, which can be life-threatening.
• Bone Problems: Long-term use of Dovato may lead to bone problems, including osteoporosis or bone fractures.

It’s essential for individuals considering Dovato to discuss the potential risks and benefits with their healthcare provider, as well as to undergo regular monitoring while taking the medication.

Why is this medication prescribed?

Dovato is prescribed for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older who weigh at least 40 kg (88 lbs). It’s typically recommended for individuals who have not previously taken antiretroviral medications or those whose HIV-1 virus is suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.

Dovato contains two active ingredients: dolutegravir and lamivudine. Dolutegravir belongs to a class of medications called integrase inhibitors, which work by blocking the action of an enzyme that the HIV virus needs to multiply. Lamivudine belongs to a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs), which also help to prevent the HIV virus from multiplying.

How should this medicine be used?

Dovato should be used exactly as prescribed by a healthcare provider. Here’s a general guideline on how Dovato should be used:

• Dosage: The recommended dosage of Dovato is one tablet taken orally once daily with or without food. The tablet should be swallowed whole and not chewed, crushed, or divided.
• Timing: Dovato can be taken at any time of the day, but it’s essential to choose a time that is convenient and easy to remember. Establishing a consistent routine can help ensure that doses are not missed.
• Adherence: It’s crucial to take Dovato consistently and not miss doses. Skipping doses or not taking the medication as prescribed can reduce its effectiveness and increase the risk of developing drug-resistant HIV.
• Storage: Dovato tablets should be stored at room temperature (between 20°C to 25°C or 68°F to 77°F) in a tightly closed container, away from moisture and heat. Keep the medication out of reach of children.
• Precautions: Before starting Dovato, it’s essential to inform the healthcare provider about any other medications, supplements, or herbal products being taken, as they may interact with Dovato. It’s also important to undergo testing to assess kidney function before starting Dovato, as dolutegravir can affect kidney function.
• Monitoring: While taking Dovato, individuals should undergo regular monitoring, including blood tests to assess HIV viral load, CD4 cell count, kidney function, and liver function. Healthcare providers may also conduct tests for hepatitis B virus infection before starting Dovato, as lamivudine can affect hepatitis B virus replication.
• Side Effects: It’s essential to be aware of potential side effects of Dovato and to promptly report any unusual or severe symptoms to a healthcare provider. Common side effects may include headache, diarrhea, nausea, and insomnia.

Always follow the specific instructions provided by a healthcare provider and refer to the medication guide or patient information leaflet for detailed usage instructions. If there are any questions or concerns about how to use Dovato, it’s important to consult with a healthcare provider for clarification and guidance

Other uses for this medicine

Dovato is primarily indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older who weigh at least 40 kg (88 lbs). However, it’s important to note that Dovato should only be used for its approved indication unless specifically prescribed for off-label use by a healthcare provider. Off-label use refers to the use of a medication for a purpose other than what it is approved for by regulatory agencies.

What special precautions should I follow?

As for special precautions to follow when using Dovato:

• Kidney Function Monitoring: Before starting Dovato and periodically during treatment, healthcare providers should assess kidney function. Dolutegravir, one of the components of Dovato, can affect kidney function. Individuals with pre-existing kidney problems or those at risk of kidney issues may require closer monitoring.
• Hepatitis B Testing: Prior to initiating Dovato, healthcare providers should test individuals for hepatitis B virus infection. This is because lamivudine, another component of Dovato, can affect hepatitis B virus replication. In individuals with HIV-1 and hepatitis B virus co-infection, discontinuation of Dovato may require consideration of both HIV-1 and hepatitis B virus treatment strategies.
• Drug Interactions: Dovato may interact with other medications, including certain antacids, laxatives, and mineral supplements containing aluminum, magnesium, or calcium. It’s important to inform healthcare providers about all medications, supplements, and herbal products being taken to avoid potential interactions.
• Pregnancy and Breastfeeding: The safety of Dovato during pregnancy and breastfeeding has not been established. Pregnant individuals or those planning to become pregnant should discuss the risks and benefits of Dovato with their healthcare provider. Similarly, breastfeeding individuals should discuss the potential risks and benefits of Dovato with their healthcare provider and consider alternative HIV treatment options if needed.
• Allergic Reactions: Individuals should be monitored for signs of allergic reactions while taking Dovato. Symptoms of an allergic reaction may include rash, fever, swollen lymph nodes, or difficulty breathing. If any signs of an allergic reaction occur, individuals should seek immediate medical attention.
• Liver Function Monitoring: Dovato can cause liver problems, including liver enlargement. Healthcare providers should monitor liver function before starting Dovato and periodically during treatment. Individuals should promptly report any symptoms of liver problems, such as jaundice (yellowing of the skin or eyes), dark urine, or abdominal pain.
• Immune Reconstitution Syndrome: Individuals starting Dovato may experience inflammatory reactions from previously acquired infections as their immune system improves. Healthcare providers should monitor for symptoms of immune reconstitution syndrome and manage them as appropriate.

It’s important to follow all instructions provided by a healthcare provider and to communicate any concerns or questions about Dovato treatment. Adhering to prescribed dosages and precautions can help optimize the effectiveness and safety of Dovato therapy.

What special dietary instructions should I follow?

Special dietary instructions for Dovato are generally not required. However, it’s important to maintain a healthy, balanced diet as part of overall wellness. If you have specific dietary concerns or restrictions, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you forget to take a dose of Dovato, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are unsure about what to do, consult your healthcare provider or pharmacist for advice. It’s important to try to take Dovato consistently as prescribed to maintain its effectiveness in managing HIV-1 infection.

What side effects can this medication cause?

Dovato, like any medication, can cause side effects. Not everyone will experience these side effects, and their severity can vary from person to person. Some common side effects of Dovato may include:

• Headache: Headaches are a common side effect reported by some individuals taking Dovato.
• Diarrhea: Some people may experience diarrhea while taking Dovato.
• Nausea: Nausea is another common side effect reported by individuals taking Dovato.
• Insomnia: Difficulty sleeping or insomnia may occur in some individuals.
• Fatigue: Feeling tired or fatigued can be a side effect of Dovato for some people.
• Dizziness: Dizziness or lightheadedness may occur, especially when standing up quickly from a sitting or lying position.
• Abnormal Dreams: Some individuals may experience vivid or abnormal dreams while taking Dovato.
• Rash: Skin rash is a potential side effect of Dovato. It’s important to notify your healthcare provider if you develop a rash while taking this medication.
• Abnormal Liver Function Tests: Dovato can affect liver function, leading to abnormal liver function test results in some individuals.
• Changes in Body Fat Distribution: Changes in body fat distribution, including increased fat in the upper back and neck (“buffalo hump”), breasts, or around the abdomen, and decreased fat in the arms, legs, and face, have been reported with certain HIV medications, although the specific occurrence with Dovato may vary.
• Other Side Effects: Other less common side effects may occur. It’s important to report any new or unusual symptoms to your healthcare provider for evaluation.

It’s essential to discuss potential side effects and any concerns with your healthcare provider before starting Dovato. Your healthcare provider can provide guidance on managing side effects and adjusting treatment as needed. Additionally, if you experience any severe or persistent side effects while taking Dovato, seek medical attention promptly.

What should I know about storage and disposal of this medication?

When it comes to storing and Dovato, here’s what you should know:

Storage:

• Store Dovato at room temperature, ideally between 20°C to 25°C (68°F to 77°F).
• Keep the medication in its original container or packaging.
• Protect Dovato from moisture and heat.
• Keep the medication out of reach of children and pets.
• Do not use Dovato if it has expired or if the packaging is damaged.

Disposal:

• Dispose of any unused or expired Dovato tablets properly.
• Do not flush Dovato down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist.
• Follow any specific disposal instructions provided by your healthcare provider, pharmacist, or local waste disposal authorities.
• If you have questions about how to dispose of Dovato, consult your healthcare provider or pharmacist for guidance.

In case of emergency/overdose

• In case of an overdose of Dovato, seek emergency medical attention or contact a poison control center immediately.
• Symptoms of an overdose may include severe dizziness, confusion, drowsiness, nausea, vomiting, and/or rapid heartbeat.
• If possible, bring the Dovato container or packaging to the healthcare provider or emergency room for identification.
• Do not attempt to induce vomiting unless instructed to do so by medical personnel.

What other information should I know?

• Inform all healthcare providers involved in your care that you are taking Dovato.
• Attend all scheduled appointments with your healthcare provider for monitoring of your HIV infection and response to treatment.
• Do not change your dose or stop taking Dovato without consulting your healthcare provider first.
• Inform your healthcare provider of any new or worsening symptoms while taking Dovato.
• Keep a list of all medications, supplements, and herbal products you are taking and share it with your healthcare provider.
• Follow any additional instructions provided by your healthcare provider or pharmacist regarding the use of Dovato.

By following these guidelines for storage, disposal, and in case of emergency/overdose, you can help ensure the safe and effective use of Dovato as part of your HIV treatment regimen.