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Patient Information Sheet
Tipranavir (marketed as Aptivus)
PDF Print Version
This is a summary
of the most important information about Aptivus. For details, talk
to your healthcare professional.
What Is The Most
Important Information About Aptivus?
-
Patients taking
Aptivus, together with 200 mg Norvir (ritonavir), may
develop severe liver disease that can cause death. If you develop
any of the following symptoms of liver problems, you should stop
taking Aptivus/ritonavir treatment and call your doctor right
away:
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tiredness,
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general ill feeling or “flu-like”
symptoms,
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loss of appetite,
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nausea (feeling sick to your stomach),
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yellowing of your skin or whites of your
eyes,
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dark (tea-colored) urine,
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pale stools (bowel movements), or
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pain, ache, or sensitivity on your right
side below your ribs.
If you have chronic
Hepatitis B or C infection, your doctor should check your blood
tests more often because you have an increased chance of developing
liver problems.
What is Aptivus?
Aptivus is a medicine
called a “protease inhibitor” that is used to treat adults with
Human Immunodeficiency Virus (HIV). Aptivus blocks HIV protease, an
enzyme which is needed for HIV to make more virus. When used with
other anti-HIV medicines, Aptivus may reduce the amount of HIV in
your blood and increase the number of CD4+ cells. Reducing the
amount of HIV in the blood may keep your immune system healthy so it
can help fight infection. Aptivus is always taken with Norvir
(ritonavir) and at the same time as Norvir. When you take Aptivus
with Norvir, you must always use at least 2 other anti-HIV
medicines.
Aptivus does not cure
HIV infection or AIDS. You may still get infections or other
conditions common in people with HIV. Aptivus does not reduce the
chance of passing HIV to others through sexual contact, sharing
needles, or being exposed to your blood.
Who Should Not Take Aptivus?
Do not take Aptivus if you:
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are allergic to tipranavir or any of the other
ingredients in Aptivus.
-
are allergic to ritonavir (Norvir).
-
have moderate to severe liver problems.
-
take any of the following types of medicines
because you could have serious side effects:
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Migraine (headache) medicines called “ergot alkaloids”. If you
take migraine medicines, ask a healthcare professional if any of
them are “ergot alkaloids”.
-
Halcion (triazolam)
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Hismanal (astemizole)
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Orap (pimozide)
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Propulsid (cisapride)
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Seldane (terfenadine)
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Versed (midazolam)
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Pacerone (amiodarone)
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Vascor (bepridil)
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Tambocor (flecainide)
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Rythmol (propafenone)
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Quinaglute (quinidine)
What Are The Risks?
Aptivus can cause
serious problems such as:
-
Liver problems, including liver failure and
death. Your doctor should do blood tests
to monitor your liver function during treatment with Aptivus.
Patients with liver diseases such as Hepatitis B and Hepatitis C
may have worsening of their liver disease with Aptivus and should
have blood tests more often.
-
Rash. Mild to
moderate rash, including flat or raised rashes or sensitivity to
the sun, have been reported in approximately 10% of patients
receiving Aptivus. Some patients who developed rash also had joint
pain or stiffness, throat tightness, or generalized itching.
-
Increased bleeding in patients with hemophilia.
This can happen in patients taking
Aptivus or other protease inhibitor medicines.
-
Diabetes and high blood sugar (hyperglycemia).
This can happen in patients taking
Aptivus or other protease inhibitor medicines. Some patients have
diabetes before starting treatment with Aptivus which gets worse.
Some patients develop diabetes during treatment with Aptivus. Some
patients will need new diabetes medicine or changes in their
current diabetes medicine.
-
Increased blood fat (lipid) levels.
Your doctor should do blood tests to monitor your
blood fat (triglycerides and cholesterol) during treatment with
Aptivus. Some patients taking Aptivus have large increases in
triglycerides and cholesterol. The long-term chance of having a
heart attack or stroke due to increases in blood fats caused by
Aptivus is not known at this time.
-
Changes in body fat.
These changes have happened in patients taking Aptivus and other
anti-HIV medicines. The changes may include an increased amount of
fat in the upper back and neck (“buffalo hump”), breast, and
around the back, chest, and stomach area. Loss of fat from the
legs, arms, and face may also happen. The cause and long-term
health effects of these conditions are not known.
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Common side effects such as
diarrhea, nausea, vomiting, stomach pain, tiredness, and headache.
Women taking birth control pills may get a skin rash. You should
report any new or continuing symptoms to your doctor right away.
The list of side effects is not complete. Ask your healthcare
professional for more information.
What Should I Tell My
Healthcare Professional?
Tell your healthcare professional about
all of your medical conditions, including if you:
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have liver problems or are
infected with Hepatitis B or Hepatitis C. These patients may have
worsening of their liver disease.
-
are allergic to sulfa
medicines.
-
have hemophilia. Aptivus may
cause increased bleeding.
-
have diabetes. Aptivus may
worsen your diabetes or high blood sugar levels.
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are pregnant or planning to
become pregnant. It is not known if Aptivus can harm your unborn
baby. You and your doctor will need to decide if Aptivus is right
for you. If you take Aptivus while you are pregnant, talk to your
doctor about how you can be in the Antiretroviral Pregnancy
Registry.
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are breast-feeding. Do not
breast-feed if you are taking Aptivus. You should not breast-feed if
you have HIV because of the chance of passing the HIV virus to your
baby. Talk with your doctor about the best way to feed your baby.
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are using estrogens for
birth control or hormone replacement. Women who use estrogens for
birth control or hormone replacement have an increased chance of
developing a skin rash while taking Aptivus. If a rash occurs, it is
usually mild to moderate, but you should talk to your doctor as you
may need to temporarily stop taking either Aptivus or the other
medicine that contains estrogen or female hormones.
Are There Any Interactions With Drugs Or Foods?
Tell your healthcare professional
about all the medicines you take including prescription and
nonprescription medicines, vitamins and herbal supplements. Aptivus
and many other medicines can interact. Sometimes serious side
effects will happen if Aptivus is taken with certain other medicines
(see “Who Should Not Take Aptivus?”).
Women taking birth control pills need
to use another birth control method. Aptivus makes birth control
pills work less well.
How Do I Take Aptivus?
- Take Aptivus exactly as your doctor has
prescribed.
- You must take Aptivus at the same time
as Norvir (ritonavir). The usual dose is 500 mg (two 250 mg
capsules) of Aptivus, together with 200 mg (two 100 mg capsules or
2.5 mL of solution) of Norvir, twice per day.
- Aptivus with Norvir must be used
together with other anti-HIV medicines.
- Aptivus comes in a capsule form and you
should swallow Aptivus capsules whole. Do not chew the capsules.
- Always
take Aptivus with food.
- Do not change your dose or stop taking
Aptivus without first talking with your doctor.
- If you take too much Aptivus, call your
doctor or poison control center right away.
- If you forget to take Aptivus, take the
next dose of Aptivus, together with Norvir (ritonavir), as soon as
possible. Do not take a double dose to make up for a missed dose.
- You should NEVER stop taking Aptivus or
your other HIV medicines without talking with your doctor.
Aptivus FDA
Approved 06/2005
Patient
Information Sheet Created 07/2005
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Date created: July
18, 2005, updated August 24, 2005 |
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