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Overview: Aptivus is a capsule you swallow and is used with another medicine to treat certain people with HIV. Common side effects can include diarrhea, nausea, vomiting, stomach pain, fever, tiredness, headache, and rash. Rash may be more common in children than in adults. Serious side effects are less likely but may include liver problems, rash, or increased blood sugar levels. You must take Aptivus with another medicine (ritonavir) and food for it to work well. Not taking it with ritonavir or taking it without food may keep it from working well. 

Uses

What is Aptivus used for?

Aptivus (tipranavir) is commonly used with another medicine to treat certain people with HIV. 

Aptivus may not be the right medicine for some of HIV infections, depending on the virus causing the infection. Viruses in some locations may have developed resistance to Aptivus, which will make it not work as well.

Aptivus may also be used for other conditions as determined by your health care provider.

How does Aptivus work (mechanism of action)?

Aptivus is a protease inhibitor. It works by binding to and blocking certain enzymes (proteases). That blocks their ability to function and stops the virus from making copies of itself. This helps lower the levels of HIV in your body to fight the infection. A lower amount of HIV in your body also helps protect and preserve your immune system.

How is Aptivus supplied (dosage forms)?

Brands and other names

  • Aptivus

Dosage forms and strengths

  • 250 mg oral capsules

How should I store Aptivus?

Before opening your bottle of Aptivus, it should be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Once the bottle has been opened, you can store it at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Aptivus capsules must be used within 60 days after opening the bottle. Throw away any remaining capsules after 60 days.

Side Effects

What are the most common side effects of Aptivus?

The most common side effects of Aptivus are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea, nausea, vomiting, or stomach pain
  • Fever
  • Tiredness
  • Headache
  • Rash (may be more common in children than in adults)

There may be other side effects of Aptivus that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Aptivus?

While less common, the most serious side effects of Aptivus are described below, along with what to do if they happen.

Severe Allergic Reactions. Aptivus may cause allergic reactions, which can be serious. Stop taking Aptivus and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Aptivus. This can sometimes lead to death. You may be at higher risk for liver damage if you have chronic hepatitis B or hepatitis C. Keep all of your appointments, including those for lab tests, while you are taking Aptivus. Your health care provider will likely use lab tests to watch for any liver damage that Aptivus may cause. Stop taking Aptivus and call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish (also called jaundice)

Brain Bleeding. Brain bleeding, which can sometimes lead to death, can happen when taking Aptivus. Your risk may be higher based on your other health conditions or medicines that you take. Tell your health care provider right away if you have new unexplained bleeding or any of the following symptoms of brain bleeding.

  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech 

Rash or Photosensitivity. Some people get a rash while taking Aptivus. The rash may be flat or raised. Your skin may also be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds. This is called photosensitivity. If you take female hormones, such as birth control pills or hormone replacement therapy, your risk may be higher. Stop taking Aptivus and call your health care provider right away if you have any of the following symptoms. 

  • Muscle or joint pain or stiffness
  • Fever
  • Your skin itches, seems, has blisters, or is peeling
  • Your throat feels tight

High Blood Sugar. Aptivus may increase your blood sugar levels, or you may even get diabetes. If you already have diabetes, taking Aptivus may make it worse. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments with your health care provider for blood tests. Call your health care provider if you have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Immune System Changes. When you start Aptivus, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your health care provider right away if you notice any of the following new symptoms of infection.

  • Fever, sweats, chills, or muscle aches
  • Swollen lymph nodes
  • Vision problems
  • Confusion, problems talking, or headache
  • Skin problems, such as a painful rash or warts
  • Cough or coughing up blood
  • Weakness or coordination problems 

Body Fat Changes. Some people who take Aptivus have changes in how their body stores fat. You may get more fat around the belly, breasts, or upper back (buffalo hump). You may lose fat in your arms, legs, or face. Talk to your health care provider if you notice any of these things. 

High Fats (Cholesterol and Triglycerides) in Your Blood. Aptivus may cause high cholesterol and triglyceride levels. You may not have symptoms of high cholesterol or triglycerides. Your health care provider may check your cholesterol levels before you start Aptivus and while you are taking it. Keep all of your appointments, including those for lab tests, while you are taking this medicine. 

Warnings & Precautions

Who should not use Aptivus?

Allergies to Ingredients. People who are allergic to any of the following should not take Aptivus.

  • Aptivus
  • Tipranavir
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Aptivus.

Liver Problems. You should not take Aptivus if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.

Drug Interactions. Aptivus should not be taken while you are using certain other medicines. Before taking Aptivus, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Aptivus before using it?

Do not take Aptivus unless it has been prescribed to you by a health care provider. Take it as prescribed. Do not change your dose or stop taking Aptivus or any other medicine for HIV without talking to your health care provider. 

You must take Aptivus with another medicine (ritonavir) and food for it to work well. Not taking it with ritonavir or taking it without food may keep it from working well. Talk to your health care provider if you have questions or concerns. 

Do not share Aptivus with other people, even if they have the same condition as you. It may harm them.

Keep Aptivus out of the reach of children. Since this medicine should be kept in a refrigerator before opening the bottle, take special precautions to keep it away from children who also use the refrigerator. 

Do not open or chew Aptivus capsules. They should be swallowed whole.

Order your refills before you run out of your medicine. Missing even a few doses can increase the chance that your HIV becomes resistant (or hard to treat). Talk to your pharmacist if you have any trouble remembering to take your medicine or order your refills on time.

Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking Aptivus. This is called photosensitivity. Use sunscreen and wear a hat and clothes that cover your skin if you need to be in the sunlight. Exposure to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your health care provider right away if any of these happen.

What should I tell my health care provider before using Aptivus?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Aptivus is right for you.

In particular, make sure that you discuss any of the following.

Sulfa Allergy. Some people who have a sulfa allergy may also be allergic to Aptivus. A sulfa allergy is a rash or more serious reaction to sulfa, or sulfonamide, medicines. Sulfa medicines include sulfamethoxazole, sulfadiazine silver, or sulfasalazine. Tell your health care provider if you have any allergies to medicines. Your health care provider can help you decide if it is safe for you to take Aptivus.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • You are at increased risk for bleeding from a medical condition or medicines that you take
  • Recent trauma or surgery or if these happen while you are taking this medicine
  • Hemophilia
  • Liver problems, including hepatitis B or C
  • High cholesterol or triglyceride levels
  • Diabetes

Pregnancy. It is not known if or how Aptivus could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Aptivus while you are pregnant or trying to get pregnant. If you become pregnant while taking Aptivus, contact your health care provider right away. They can sign you up for the Pregnancy Registry by calling 800-258-4263. This registry collects safety information about the use of antiepileptic medicines during pregnancy. 

Breastfeeding. It is not known if Aptivus passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Aptivus. You may be able to give HIV to your child through your breast milk. If your child has HIV, breastfeeding while taking Aptivus may increase the risk that your child’s HIV will be resistant (hard to treat). Your child may also have side effects from the medicine if it does pass into breast milk. See the Side Effects section for more details.

How can I get more information about Aptivus?

For more information about Aptivus, you can visit the drugmaker’s website at www.boehringer-ingelheim.com/human-health/products/aptivus or call them at 800-542-6257.

Interactions

Does Aptivus interact with foods or drinks?

You should take Aptivus at the same time as you take your ritonavir. Ritonavir must be taken with food, so you need to take Aptivus with food, as you take them together. Talk to your health care provider if you have any concerns.

It is unknown if drinking alcohol will affect Aptivus, but heavy drinking can slow your immune response and make it harder for your body to fight infections.

Does Aptivus interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Aptivus.

  • Alfuzosin (Uroxatral), which is a medicine that may be used for trouble peeing due to an enlarged prostate
  • Antiarrhythmics, such as amiodarone, flecainide, propafenone, or quinidine, which is a medicine used to control your heart rate or rhythm
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • An ergot, such as dihydroergotamine (Migranal or Trudhesa) or ergotamine (Ergomar), which is a medicine used to treat migraine
  • St. John’s wort, which is a supplement that may be used for depression
  • An antipsychotic, such as lurasidone (Latuda), pimozide (Orap), or quetiapine, which is a medicine for certain mental health conditions 
  • Sildenafil (Revatio), which is a medicine used for pulmonary arterial hypertension (PAH)
  • A benzodiazepine, such as midazolam that you swallow or triazolam, which is a medicine used for anxiety, muscle spasms, or seizures
  • A statin, such as atorvastatin (Lipitor and others), lovastatin (Altoprev, Mevacor), or simvastatin (Zocor), which is a medicine used to lower cholesterol
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are medicines used for fungal infections
  • Any medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin
  • Divalproex sodium, valproate sodium (Depakote and others), or valproic acid, which are medicines used for seizures and other conditions
  • Desipramine (Norpramin) or trazodone (Desyrel), which are medicines commonly used to for depression
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
  • Colchicine (Colcrys, Gloperba, Lodoco, Mitigare), which is a medicine commonly used for gout
  • A calcium channel blocker, such as diltiazem (Cardizem CD and others), felodipine (Plendil), nicardipine (Cardene), nisoldipine (Sular), or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
  • Estrogen, which is found in certain birth control pills, patches, creams, rings, or vaginal suppositories 

Many other medicines may alter the blood levels of Aptivus, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Aptivus. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Aptivus?

If you or someone else has used too much Aptivus, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Aptivus?

If you miss a dose, take it as soon as you remember. Be sure to take it with ritonavir and food. Do not take double or extra doses.