1 What is Aptivus?

Brand: Aptivus

Generic: Tipranavir

Aptivus is used in combination with ritonavir (Norvir®) to treat an infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have already received HIV treatment.

Tipranavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease.

This drug will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

  • Capsule, Liquid Filled
  • Solution

2 What to Know Before Using

Before using Aptivus, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that. The use of tipranavir is contraindicated in those who are hypersensitive to this drug or any of the ingredients of the formulation.

Make sure you inform your doctor if you have any other medical problems, especially:

  • Bleeding problems (e.g., hemophilia)—Use with caution. May increase the chance of bleeding
  • Diabetes mellitus 
  • Hyperglycemia (high blood sugar)—May increases the amount of sugar in your blood
  • Hyperlipidemia (high cholesterol or fats in the blood) 
  • Liver problems (including hepatitis B or C)—Use with caution. May make these conditions worse
  • Liver disease, moderate or severe—Should not be used in patients with this condition
  • Sulfa allergy, known or suspected—Use with caution. May cause side effects to be worse

Because of drug-drug interactions, certain medicines should not be used along with this medicine. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects. In addition, you should not use any of the following medicines while you are taking tipranavir.

Using these medicines together with Aptivus may increase your chance of having serious medical problems:

  • Alfuzosin (Uroxatral®) 
  • Amiodarone (Cordarone®, Pacenone®) 
  • Bepridil (Vascor®) 
  • Cisapride (Propulsid®) 
  • Ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Methergine®, or Migranal®) 
  • Flecainide (Tambocor®) 
  • Lovastatin (Altocor®, Mevacor®) 
  • Oral midazolam (Versed®) 
  • Pimozide (Orap®) 
  • Propafenone (Rythmol®) 
  • Quinidine (Cardioquin®, Quinaglute dura®) 
  • Rifampin (Rifadin®, Rimactane®) 
  • Sildenafil (Revatio®) 
  • Simvastatin (Simcor®, Vytorin®, Zocor®) 
  • Triazolam (Halcion®)

Animal reproduction studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women. Thus, this drug should be used during pregnancy only if clearly needed.

Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

3 Proper Usage

To use Aptivus properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice.

The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well. This medicine comes with patient information.

You should read and follow the instructions carefully before using this medicine; however, the dosage schedule for treatment of HIV infection is described below:

For oral dosage forms (capsules or oral liquid):

  • Adults—500 milligrams (mg) or 5 milliliters (mL) of tipranavir and 200 mg of ritonavir (Norvir®) two times per day.
  • Children 2 to 18 years of age—Dose is based on body weight or body size and must be determined by your doctor. The dose is usually 14 milligrams (mg) per kilogram (kg) of body weight of tipranavir plus 6 mg per kg of body weight of ritonavir (Norvir®), or 375 mg/m(2) of body size of tipranavir plus 150 mg/m(2) of body size of ritonavir two times per day. Your doctor may adjust your dose if needed. However, the dose should not be more than the recommended adult dose.
  • Children younger than 2 years of age—Use and dose must be determined by your doctor.

You should use this medicine following the directions were given by your doctor. If you miss a dose of this medicine, take it as soon as possible. But, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Do not use this drug in larger amounts, more often, or for a longer time than your doctor ordered. Further, it is advised to store the medicine in a closed container at room temperature away from heat, moisture, and direct light.

All kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

4 Precautions to Take

Before using Aptivus, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better prognosis of the patients:

Tipranavir may decrease the effects of some oral contraceptives (i.e. birth control pills). To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

This medicine may cause intracranial hemorrhage (bleeding in the brain). Make sure your doctor knows if you have a bleeding disorder or any medical condition that increases your chance of bleeding. Call your doctor right away if you have any unusual or unexplained bleeding.

Stop using this medicine and check with your doctor right away if you or your child have pain in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have more than one of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; fever or chills; itching; joint or muscle pain; severe rash; red skin lesions; sunburn; throat tightness; or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

Above all, do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

5 Potential Side Effects

Make sure you meet with your doctor in using Aptivus to avoid unwanted potential side effects. Along with the beneficial effects, this medicine may cause some unwanted effects that may not need any medical attention.

These side effects usually go away during the treatment episode as your body adjusts to the medicine. Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

  • Abdominal or stomach pain
  • Bleeding gums
  • Confusion
  • A cough producing mucus
  • Coughing up blood
  • Diarrhea
  • Difficulty with breathing or swallowing
  • Discouragement
  • Dizziness
  • Fat redistribution
  • Feeling sad or empty
  • Fever
  • Generalized tiredness or weakness
  • Headache
  • Increased menstrual flow or vaginal bleeding
  • Irritability
  • Loss of appetite
  • Lack or loss of strength
  • Loss of interest or pleasure
  • Nausea or vomiting
  • Nosebleeds
  • Paralysis
  • Prolonged bleeding from cuts
  • Red or black, tarry, or light-colored stools
  • Red or dark brown urine
  • Rash
  • Sleeplessness
  • Shortness of breath
  • Sudden severe weakness
  • Tightness in the chest
  • Unusual bleeding
  • Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.