Selzentry

Selzentry is a prescription medication used in combination with other treatments to treat certain strains of HIV.

Selzentry belongs to a group of drugs called antivirals. It works by preventing the virus from entering white blood cells.

This medication comes in tablet and oral solution form and is usually taken twice daily with or without food.

Swallow Selzentry tablets whole. Do not chew the tablets.

Common side effects include upper respiratory infection, cough, rash and dizziness.

Selzentry is a prescription medication used in combination with other treatments to treat certain strains of HIV.

This medication is approved for patients 2 years of age and older weighing at least 10 kg.

Selzentry is not for patients with dual/mixed- or CXCR4-tropic HIV-1.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer Laboratories Div Pfizer Inc.

• ViiV Healthcare Company

There have been serious side effects when Selzentry has been given with other anti-HIV drugs. See "Drug Precautions" section.

The most common side effects of Selzentry include:

• colds
• cough
• fever
• rash
• dizziness

Tell your health care provider about any side effect that bothers you or does not go away.

These are not all of the side effects with Selzentry. For more information, ask your health care provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain other medicines may affect the levels of Selzentry in your blood. Your health care provider may need to change your dose of Selzentry when you take it with certain medicines.

The levels of Selzentry in your blood may change and your health care provider may need to adjust your dose of Selzentry when taking any of the following medications together with Selzentry:

• darunavir (Prezista)
• lopinavir/ritonavir (Kaletra, Norvir)
• atazanavir (Reyataz)
• saquinavir (Invirase)
• nelfinavir (Viracept)
• indinavir (Crixivan)
• fosamprenavir (Lexiva)
• etravirine (Intelence)
• carbamazepine (Tegretol)
• phenytoin (Dilantin)
• Ritonavir (Norvir)
• delavirdine (Rescriptor)
• ketoconazole (Nizoral)
• itraconazole (Sporanox)
• clarithromycin (Biaxin)
• nefazodone (Serzone)
• telithromycin (Ketek)
• efavirenz (Sustiva, Atripla)
• rifampin (Rifadin, Rifater)
• phenobarbital (Luminal)

Do not take products that contain St. John's Wort (hypericum perforatum). St. John's Wort may lower the levels of Selzentry in your blood so that it will not work to treat your CCR5-tropic HIV infection.

Know the medicines you take. Keep a list of your medicines. Show the list to your health care provider and pharmacist when you get a new medicine.

Serious side effects have occurred with Selzentry, including liver problems (liver toxicity). An allergic reaction may happen before liver problems occur. Stop taking Selzentry and call your health care provider right away if you get any of the following symptoms:

• an itchy rash on your body (allergic reaction)
• yellowing of your skin or whites of your eyes (jaundice)
• dark (tea-colored) urine
• vomiting
• upper right stomach area (abdominal) pain

People with severe kidney problems or who are on hemodialysis and are taking certain other medications should not take Selzentry. Talk to your healthcare provider before taking this medicine if you have kidney problems.

Other serious side effects include:

• Heart problems including heart attack.
• Low blood pressure when standing up (postural hypotension). Low blood pressure when standing up can cause dizziness or fainting. Do not drive a car or operate heavy machinery if you have dizziness while taking Selzentry.
• Changes in your immune system. A condition called Immune Reconstitution Syndrome can happen when you start taking HIV medicines. Your immune system may get stronger and could begin to fight infections that have been hidden in your body such as pneumonia, herpes virus or tuberculosis. Tell your health care provider if you develop new symptoms after starting your HIV medicines.
• Possible chance of infection or cancer. Selzentry affects other immune system cells and therefore may possibly increase your chance for getting other infections or cancer.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Selzentry there are no specific foods that you must exclude from your diet when receiving Selzentry.
 

Before you take Selzentry, tell your health care provider if you:

• have liver problems including a history of hepatitis B or C
• have heart problems
• have kidney problems
• have low blood pressure or take medicines to lower blood pressure
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant.

It is not known if Selzentry may harm your unborn baby.
Antiretroviral Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your health care provider about how you can take part in this registry.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is recommended that HIV-positive women should not breastfeed their babies. This is because of the chance of passing HIV to your baby. You should not breastfeed if you are taking Selzentry because the risk to your baby is unknown. Talk with your health care provider about the best way to feed your baby.

Take Selzentry exactly as prescribed by your health care provider.

Selzentry comes in tablet and oral solution forms. Your health care provider will prescribe the dose that is right for you.

Before starting treatment, your health care provider will test you for CCR5 tropism. 

If you are taking the tablets, make sure to swallow Selzentry tablets whole. Do not chew the tablets.

• Take Selzentry 2 times a day.
• Take Selzentry with or without food.
• Always take Selzentry with other anti-HIV drugs as prescribed by your health care provider.

Do not change your dose or stop taking Selzentry or your other anti-HIV medicines without first talking with your health care provider.

• If you take too much Selzentry, call your health care provider or the poison control center right away.
• If you forget to take Selzentry, take the next dose of Selzentry as soon as possible and then take your next scheduled dose at its regular time. If it is less than 6 hours before your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
• It is very important to take all your anti-HIV medicines as prescribed. This can help your medicines work better. It also lowers the chance that your medicines will stop working to fight HIV (drug resistance).
• When your Selzentry supply starts to run low, ask your health care provider or pharmacist for a refill. This is very important because the amount of virus in your blood may increase and Selzentry could stop working if it is stopped for even a short period of time.

Your healthcare provider will determine the best Selzentry dosage for you based on several factors including:

• other medications you are taking
• how well your kidneys function
• how your body tolerates Selzentry 

The recommended dosage range in adults is 150 mg twice daily to 600 mg twice daily.

The recommended dose in children is based on weight and should not exceed the recommended adult dose. 

If you take too much Selzentry, call your health care provider or the poison control center right away.

• Store Selzentry tablets at room temperature from 59°F to 86°F (15°C to 30°C).
• Store Selzentry oral solution from 68°F to 77°F (20°C to 25°C).
• Safely throw away medicine that is out of date or that you no longer need.

Keep Selzentry and all medicines out of the reach of children.

WARNING: HEPATOTOXICITY

Hepatotoxicity has been reported with Selzentry use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of Selzentry should be evaluated immediately.