| Aptivus side effects zhion@zhion.com November 15, 2005 |
Patient Information Sheet
Tipranavir (marketed as Aptivus)
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:
tiredness,
general ill feeling or “flu-like” symptoms,
loss of appetite,
nausea (feeling sick to your stomach),
yellowing of your skin or whites of your eyes,
dark (tea-colored) urine,
pale stools (bowel movements), or
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:
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:
Migraine (headache) medicines called “ergot alkaloids”. If you take
migraine medicines, ask a healthcare professional if any of them are “ergot
alkaloids”.
Halcion (triazolam)
Hismanal (astemizole)
Orap (pimozide)
Propulsid (cisapride)
Seldane (terfenadine)
Versed (midazolam)
Pacerone (amiodarone)
Vascor (bepridil)
Tambocor (flecainide)
Rythmol (propafenone)
Quinaglute (quinidine)
What Are The Risks?
Aptivus can cause serious side effects or 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.
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:
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.
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.
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.
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
Tipranavir (marketed as Aptivus)
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:
tiredness,
general ill feeling or “flu-like” symptoms,
loss of appetite,
nausea (feeling sick to your stomach),
yellowing of your skin or whites of your eyes,
dark (tea-colored) urine,
pale stools (bowel movements), or
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:
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:
Migraine (headache) medicines called “ergot alkaloids”. If you take
migraine medicines, ask a healthcare professional if any of them are “ergot
alkaloids”.
Halcion (triazolam)
Hismanal (astemizole)
Orap (pimozide)
Propulsid (cisapride)
Seldane (terfenadine)
Versed (midazolam)
Pacerone (amiodarone)
Vascor (bepridil)
Tambocor (flecainide)
Rythmol (propafenone)
Quinaglute (quinidine)
What Are The Risks?
Aptivus can cause serious side effects or 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.
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:
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.
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.
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.
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
PHARMCEUTICAL
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
 |  |  |  |