Basic
Informations
Prezista is an HIV medication.
It is in a category of HIV medicines called protease inhibitors.
Prezista prevents cells infected by HIV from producing new virus.
This reduces the amount of virus in your body.
Prezista must be used with low-dose Norvir (ritonavir) and in
combination with other HIV drugs.
Prezista, manufactured by Tibotec Therapeutics, a division of
Centocor Ortho Biotech Products, LP, was initially approved by the
U.S. Food and Drug Administration (FDA) on June 23, 2006, for
treatment-experienced HIV-positive adults. It was approved for
HIV-positive people beginning treatment for the first time on
October 22, 2008.
Drugs
Interactions
Because of the ways Prezista
and Norvir are metabolized (broken down) in the body, they can
interact with many other medications used to treat HIV, AIDS-related
complications, and other diseases. Prezista/Norvir may cause blood
levels of other medications to be become too low (which can decrease
their effectiveness) or high (which can increase the risk of side
effects). Similarly, other medications may cause blood levels of
Prezista and/or Norvir to become too low or high.
Tell your doctors and pharmacists about all medicines you take. This
includes those you buy over-the-counter and herbal or natural
remedies, such as St. John's wort. Bring all your medicines when you
see a doctor, or make a list of their names, how much you take, and
how often you take them. Your doctor can then tell you if you need
to change the dosages of any of your medications.
The following medications
should not be taken while you are being treated with Prezista/Norvir
(this list includes medications that are contraindicated—should not
be taken together—according to both the Prezista and Norvir
packaging information):
-
Antifungals: Vfend
(voriconazole)
-
Anti-seizure medications:
Tegretol (carbamazepine), Luminal (phenobarbital), Dilantin (
phenytoin)
-
Acid reflux/heartburn
medications: Propulsid (cisapride)
-
Antibiotics: Rifadin (rifampin)
-
Antimigraine medications:
Methergine, Methylergometrine (methylergonovine); Ergostat,
Cafergot, Ercaf, Wigraine (ergotamine); Ergotrate, Methergine (ergonovine);
or D.H.E. 45, Migranal (dihydroergotamine)
-
Antihistamines: Hismanal (astemizole)
or Seldane (terfenadine)
-
Cholesterol-lowering drugs
(statins): Zocor (simvastatin) and Mevacor (lovastatin)
-
Heart medications:
Cordarone (amiodarone), Vascor (bepridil), Tambocor (flecainide),
Rythmol (propafenone), or Quinaglute/Quinidex (quinidine)
-
Antipsychotics: Orap (pimozide)
-
Sedatives: Versed (midazolam)
and Halcion (triazolam)
-
Enlarged prostate:
Uroxatral (alfuzosin)
-
Pulmonary Hypertension:
sildenafil, used as Revatio
-
Herbal products: St.
John's wort
HIV protease inhibitors can
interact with Prezista/Norvir. Kaletra (lopinavir/ritonavir) and
Invirase (saquinavir) can significantly decrease blood levels of
Prezista, hence it is not recommended that Prezista be combined with
Kaletra or Invirase. Taking Prezista and Crixivan together can cause
the levels of both drugs to increase in the bloodstream. Prezista/Norvir
does not appear to increase or decrease blood levels of Reyataz (atazanavir),
nor does Reyataz appear to increase or decrease blood levels of
Prezista/Norvir. In turn, it may be possible to combine these two
PIs.
HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs) can
also interact with Prezista/Norvir. Prezista/Norvir can increase
levels of Sustiva (efavirenz) [and to a lesser extent Viramune (nevirapine)]
in the blood. Combining Prezista/Norvir with Sustiva should be done
with caution.
Prezista/Norvir can increase levels of Viread (tenofovir), a
nucleotide reverse transcriptase inhibitor, in the blood. However,
these two drugs can be combined without any dose adjustments
(although it may be necessary to watch carefully for kidney damage,
a potential side effect of Viread). Videx/Videx EC (didanosine) must
be taken on an empty stomach. In turn, if Videx/Videx EC is used in
the same regimen as Prezista/Norvir, it should be taken one hour
before or two hours after Prezista/Norvir (which should be taken
with food).
Prezista/Norvir can interact with some medications used to treat
thrush (candidiasis) and other fungal infections. Prezista/Norvir
increases Nizoral (ketoconazole) and may increase Sporanox (itraconazole)
levels in the bloodstream. For people taking Prezista/Norvir who
also need to take Sporanox or Nizoral, the daily dose of Sporanox or
Nizoral should not exceed 200mg. It is also possible that Prezista/Norvir
decreases Vfend (voriconazole) levels in the blood (Vfend should not
be taken if you are on an HIV drug regimen that contains Norvir).
Prezista/Norvir can interact with some medications used to treat TB,
MAC, and other bacterial infections. Prezista/Norvir raises Biaxin (clarithromycin)
levels in the bloodstream. The dose of Biaxin does not need to be
decreased, although this is recommended in people with altered
kidney function. Prezista/Norvir can also increase Mycobutin (rifabutin)
levels in the bloodstream (Mycobutin can also increase Prezista
levels in the bloodstream). If Mycobutin is taken at the same time
as Prezista/Norvir, it is recommended that the Mycobutin dose be
reduced to 150mg every other day. Prezista/Norvir should not be used
with Rifadin (rifampin), a common antibiotic used to treat TB.
Prezista/Norvir may interact with calcium channel blockers,
medications used to treat heart disease. Studies of Prezista/Norvir
combined with calcium channel blockers have not yet been conducted.
Healthcare providers should be cautious when prescribing Prezista/Norvir
with either Cardizem (diltiazem), Plendil/Lexxel (felodipine),
Cardene (nicardipine), Sular (nisoldipine), or Calan/Verelan (verapamil).
Prezista/Norvir can increase the blood levels of the heart
medications Vascor (bepridil), lidocaine, Quinidex (quinidine) and
Cardarone (amiodarone). These medications should be used with
caution if taken with Prezista/Norvir and monitoring blood levels of
these drugs is recommended, if available. Prezista/Norvir can also
significantly increase blood levels of Lanoxin (digoxin). The lowest
dose of Lanoxin should initially be used and monitoring Lanoxin
blood levels is recommended.
Prezista/Norvir can decrease levels of the blood thinner Coumadin (warfarin)
in the bloodstream. Conducting blood coagulation (clotting) testing
may be necessary.
Prezista/Norvir may increase blood levels of Norpramin (desipramine),
a drug used to treat depression. The dose of Norpramin may need to
be decreased. Prezista/Norvir may also decrease levels of Zoloft (sertraline)
and Paxil (paroxetine). It may be necessary to increase Zoloft of
Paxil dosing if also using Prezista/Norvir.
Cholesterol-lowering drugs, also known as "statins," can interact
with Prezista/Norvir. There are two statins that should not be used
with Prezista/Norvir: Zocor (simvastatin) and Mevacor (lovastatin).
Levels of these two drugs can become significantly increased in the
bloodstream if they are combined with Prezista/Norvir, which
increases the risk of side effects. The statin believed to be the
safest in combination with Prezista/Norvir is Lescol (fluvastatin).
It is also possible to take Prezista/Norvir with Lipitor (atorvastatin),
or Crestor (rosuvastatin) although Prezista/Norvir can increase the
level of these drugs in the bloodstream (if Lipitor or Crestor are
prescribed, it's best to begin treatment with the lowest possible
dose of the drug and then increase the dose if necessary or else use
a different drug.) While the FDA-approved packaging information for
Prezista suggests that Pravachol (pravastatin) can also be used,
Tibotec does not recommend combining Pravachol with Prezista/Norvir.
Prezista can increase blood levels of cochicine, which is used to
treat gout. Lower doses of colchicine are recommended, and the two
drugs should not be used together in people with liver or kidney
impairment.
Neoral, Sandimmune, Gengraf (cyclosporine), Prograf (tacrolimus),
Rapamune (sirolimus) are all examples of immune-suppressants, often
prescribed for patients who have undergone an organ/tissue
transplant. Prezista/Norvir can increase levels of these drugs in
the blood. In turn, it is necessary to carefully monitor blood
levels of these drugs if they are combined with Prezista/Norvir.
Prezista/Norvir can increase blood levels of Advair, Flovent, or
Flonase (fluticasone), the inhalable medications that are used to
treat allergies and asthma. In turn, these drugs may decrease blood
levels of Prezista/Norvir. Alternatives to these drugs should be
considered, especially for long-term use. Prezista can increase
blood levels of an asthma medication called Serevent (salmeterol), a
drug that is used to open the air passages in the lungs during an
asthma attack. This can result in heart rhythm problems. Use of the
two drugs together is not recommended.
Another painkiller, methadone, commonly used to treat drug heroin
addiction, can interact with Prezista/Norvir. Methadone levels in
the bloodstream can decrease when combined with Prezista/Norvir.
Because of this, it might be necessary to increase the dose of
methadone.
Desyrel (trazodone) is used to treat depression. Prezista/Norvir can
increase blood levels of this drug, leading to an increase risk of
Desyrel side effects. Using a lower dose of Desyrel may be
necessary.
Prezista/Norvir decreases the amount of oral contraceptives (taken
by women to help avoid pregnancy) in the bloodstream. This means
that there may be a higher risk of becoming pregnant if Prezista/Norvir
and oral contraceptives are taken at the same time. To reduce the
risk of pregnancy, barrier protection (e.g., condoms) should be
used.
There is a class of drugs, known as PDE-5 inhibitors that are used
to treat both erectile dysfunction and pulmonary arterial
hypertension. Their brand names differ, depending on their use.
Prezista/Norvir can significantly increase blood levels of these
drugs.
When used to treat erectile dysfunction, it is best to use a lower
dose of Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil)
in order to reduce the risk of side effects. When used to treat
pulmonary arterial hypertension, the dose of tadalafil (Adcirca)
must be reduced if combined with Prezista/Norvir. Revatio (sildenafil)
and Prezista/Norvir should not be used together.
Tracleer (bosenstan) is another type of drug used to treat pulmonary
arterial hypertension, called an endothelin receptor antagonist.
Prezista/Norvir can increase Tracleer blood levels, so the dose of
Tracleer should be reduced.
Side
Effects
The most common side effects
reported by patients taking Prezista and Norvir in clinical trials
included diarrhea, nausea, headache, and abdominal pain. Some
patients receiving Prezista/Norvir experienced skin rashes; most
were mild-to-moderate. If a severe rash occurs while taking Prezista/Norvir,
patients should contact their healthcare providers immediately.
Prezista, a sulfa-containing drug, should be used with caution in
patients with a known sulfa allergy.
Some people may experience large increases in their lipid levels
(triglycerides and cholesterol) while being treated with protease
inhibitors. However, it is not yet known what effect, if any,
Prezista will have on lipids.
Diabetes and high blood sugar may occur in people who take Prezista
or other protease inhibitors.
HIV drug regimens containing protease inhibitors, including Prezista/Norvir,
may cause abnormal body-shape changes (lipodystrophy; including
increased fat around the abdomen, breasts, and back of the neck, as
well as decreased fat in the face, arms, and legs). These side
effects of HIV drug therapy are reviewed in our lesson on
lipodystrophy.
HIV medications, such as Prezista, can increase the risk of bleeding
in hemophiliacs.
Drug-induced hepatitis (liver injury) has been reported in people
taking Prezista. This usually occurred in people who had extremely
low CD4 cells, were taking multiple other medications and who were
also infected with hepatitis B virus (HBV) and/or hepatitis C virus
(HCV). People taking Prezista who are coinfected with HBV or HCV, or
who have a history of liver damage, should have their liver function
closely monitored by their healthcare providers. Stopping Prezista
treatment may be necessary, in consultation with a healthcare
provider, in the case of abnormal liver enzymes or symptoms of liver
damage (i.e. fatigue, nausea, yellow eyes and skin, dark urine and
liver tenderness).
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