Tivicay

(Dolutegravir Sodium)

The active ingredient in Tivicay is dolutegravir sodium, a type of HIV integrase strand transfer inhibitor (INSTI). Integrase is the enzyme (protein) that HIV employs to insert genetic information into your cells. Once this happens, HIV causes your cells to replicate themselves. Tivicay acts by inhibiting integrase, so preventing HIV from growing and spreading.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Tivicay. However, the following is a synopsis of the general guidelines for the use of Tivicay:

• You can take Tivicay with or without food.
• Do not break or chew a Tivicay PD dispersible tablet whole. Swallow the tablet whole or dissolve it in a small amount of water. Allow the tablet to disperse (it will not fully dissolve). Stir the mixture and serve it to the youngster right away. The amount of water required depends on the number of tablets in your child's dose. Follow the directions that came with your medicine.
• If you are also taking calcium or iron supplements (including vitamins/minerals that contain calcium or iron), take dolutegravir at least 2 hours before.
• Dolutegravir doses in children are calculated based on their weight. If your child gains or loses weight, their dosage requirements may change.
• For children receiving Tivicay PD tablets for oral suspension, refer to the Instructions for Use that accompany the medication for complete instructions on how to make a dosage.
• Tivicay PD can be ingested whole or dispersed in drinking water; it should not be chewed, chopped, or crushed.
• Tivicay tablets and Tivicay PD tablets for oral suspension are not interchangeable. To avoid using the wrong medicine, ensure that you receive the correct version of Tivicay every time your or your child's prescription is filled.
• While using Tivicay, you may require frequent blood tests to measure your CD4 cell count and viral load.
• If you have ever had hepatitis B, dolutegravir may cause the infection to become active or worsen. You may require frequent liver function tests while taking this medication and for several months after stopping.

The most common side effects of Tivicay seen in clinical trials include:

• Higher lipase levels.
• High blood sugar levels.
• Higher creatinine kinase levels.
• Dizziness.
• Feeling tired.
• Headache.

Some individuals may experience serious side effects while using Tivicay. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reactions include fever, skin rash, hives, intense weariness, body aches, mouth sores, blisters, and difficulty breathing.
• Serious liver problems include nausea, vomiting, a lack of appetite, pain on the right side of the stomach, yellowing of the skin or eyes, black urine, and light stool.

These are not all of the possible side effects of Tivicay. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Tivicay, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Tivicay should not be used if you are allergic to dolutegravir or are on dofetilide (Tikosyn).
• Liver problems, specifically hepatitis B or C.

Tivicay should not be used if you have a hypersensitivity to dolutegravir or are currently taking dofetilide (Tikosyn).

Tivicay will begin working with your first dose. It needs to be taken every day as prescribed by your doctor to keep the virus under control.

When Tivicay is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Calcium, magnesium, or aluminum-containing antacids or laxatives (such as Amphojel, Di-Gel, Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), as well as the ulcer medication sucralfate (Carafate).
• Calcium or iron-containing vitamin or mineral supplements (if you take Tivicay with food, you can take these supplements concurrently).
• Metformin-based oral diabetic treatment.
• Tuberculosis medicine containing rifampin.
• St. John’s wort.
• Other HIV medications include abacavir, lamivudine, efavirenz, raltegravir, rilpivirine, etravirine, fosamprenavir/ritonavir, nevirapine, and tipranavir/ritonavir.
• Medication for seizures includes carbamazepine, oxcarbazepine, phenobarbital, and phenytoin.

Tivicay Oral Tablets:

Adults: The normal dose is a 50 mg tablet taken orally once or twice daily.

Children 4 weeks and older, weighing at least 30 pounds: The dosage will be based on your child's weight. The normal dose is 40 mg or 50 mg taken orally once daily.

Tivicay PD oral tablets for suspension:

Children 4 weeks and older, weighing at least 7 pounds: The dosage will be based on your child's weight. The normal dose is 5 mg to 30 mg by mouth once daily. This formulation is recommended for children weighing less than 44 pounds.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

Store at room temperature and keep out of reach of children.

ViiV Healthcare is the company that manufactures Tivicay.

There are no lower-cost generic-name versions available of Tivicay.

To control your HIV infection and protect your disease from worsening, you must continue to take all of your medications unless your doctor tells you to stop.

Tivicay may be harmful to an unborn infant if taken during conception or the first 12 weeks of pregnancy. Use effective birth control to avoid pregnancy and notify your doctor if you become pregnant. If HIV is not treated during pregnancy, it can be passed on to your baby. If you are pregnant, your name may be added to a registry to monitor any effects of antiviral medication on the baby. To control HIV, take your meds as prescribed.

If you take Tivicay while you are pregnant, you should enroll in the Antiretroviral Pregnancy Registry (APR). It collects information about you and your baby while on Tivicay. You can call 1-800-258-4263 for more information.

Women who are HIV or AIDS positive should not breastfeed their babies. Even if your kid is born HIV-free, the virus may be transmitted to the newborn through your breast milk.