PREZISTA
Indication
PREZISTA, co-administered with 100 mg ritonavir
(PREZISTA/r), an with other antiretroviral agents (ARV...
 The recommended oral dose of PREZISTA is 600
mg (one 600-mg or two 300-mg tablets) bid
taken with ritonavir 100 mg bid w...
 Drug Interactions
 Co-administration of PREZISTA/r is
contraindicated with drugs that are highly
dependent on CYP3A for...
 Coadministration is not recommended with
carbamazepine, phenobarbital, phenytoin,
rifampin, lopinavir/ritonavir,
saquina...
 PREZISTA is contraindicated in patients with known
hypersensitivity to any of its ingredients
 PREZISTA must be coadmin...
 Severe skin rash, including erythema multiforme
and Stevens-Johnson Syndrome, has been
reported in subjects receiving PR...
 HOW DOES PREZISTA WORK?
 PREZISTA blocks HIV protease, an enzyme which is
needed for HIV to multiply. When used with ot...
 CONTRAINDICATIONS
 PREZISTA is contraindicated in patients with known
 hypersensitivity to any of the ingredients of t...
 CAN PREZISTA BE TAKEN WITH OTHER
 MEDICATIONS?
 Tell your doctor about all the medicines you take
including prescripti...
 HOW SHOULD I STORE PREZISTA
TABLETS?
 Store PREZISTA tablets at room
temperature (77°F (25°C)).
 Short-term exposure t...
 DOES PREZISTA REDUCE THE RISK OF
PASSING HIV
 TO OTHERS?
 PREZISTA does not reduce the risk of
passing HIV to others t...
DOES PREZISTA CURE HIV OR AIDS?
PREZISTA does not cure HIV infection or AIDS. At present,
there is no cure for HIV infecti...
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PREZISTA presentation

Published on: Mar 4, 2016
Source: www.slideshare.net


Transcripts - PREZISTA presentation

  • 1. PREZISTA Indication PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r), an with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV) infection in ARV treatment experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor (PI). This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from 2 controlled trials of PREZISTA/r in combination with other ARVs. Both studies were conducted in clinically advanced, treatment- experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing ARV therapy.
  • 2.  The recommended oral dose of PREZISTA is 600 mg (one 600-mg or two 300-mg tablets) bid taken with ritonavir 100 mg bid with food (the type of food does not affect exposure to PREZISTA)  No PREZISTA dose adjustment required in patients with moderate renal impairment.(creatinine clearance between 30-60 mL/min). There are no pharmacokinetic data available in patients with severe renal impairment or end-stage renal disease  No PREZISTA dose adjustment required in patients with mild or moderate hepatic impairment.  PREZISTA/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment
  • 3.  Drug Interactions  Co-administration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (eg, astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events.
  • 4.  Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir,lovastatin, pravastatin, simvastatin, or products containing St. John’s wort (Hypericum perforatum)  Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/r. This list of potential drug interactions is not complete
  • 5.  PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients  PREZISTA must be coadministered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer  PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures  Drug-induced hepatitis (eg, acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/r. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/r.
  • 6.  Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA  during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical  trials (n=924), rash (all grades, regardless of causality) occurred in 7% of subjects treated with PREZISTA; discontinuation due to rash was 0.3%. Rashes were generally mild-to-moderate, self- limiting, and maculopapular. PREZISTA should be discontinued if severe rash develops
  • 7.  HOW DOES PREZISTA WORK?  PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA may reduce the amount of HIV in your blood (called “viral load”) and increase your CD4 (T) cell count. HIV infection destroys CD4 (T) cells, which are important to the immune system.  The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system and, thus, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA is always taken with and at the same time as 100 mg of ritonavir (NORVIR®), in combination with other anti-HIV medicines.  PREZISTA should also be taken with food.
  • 8.  CONTRAINDICATIONS  PREZISTA is contraindicated in patients with known  hypersensitivity to any of the ingredients of the product.  Co-administration of PREZISTA/rtv is contraindicated with  drugs that are highly dependent on CYP3A for clearance  and for which elevated plasma concentrations are  associated with serious and/or life-threatening events  (narrow therapeutic index).
  • 9.  CAN PREZISTA BE TAKEN WITH OTHER  MEDICATIONS?  Tell your doctor about all the medicines you take including prescription and non prescription medicines, vitamins, and herbal supplements, including St. John’s wort (Hypericum perforatum). PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines
  • 10.  HOW SHOULD I STORE PREZISTA TABLETS?  Store PREZISTA tablets at room temperature (77°F (25°C)).  Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your tablets.
  • 11.  DOES PREZISTA REDUCE THE RISK OF PASSING HIV  TO OTHERS?  PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles.
  • 12. DOES PREZISTA CURE HIV OR AIDS? PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Because of this, it is very important for you to remain under the care of a doctor. Although PREZISTA is not a cure for HIV or AIDS. PREZISTA can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection) and eventually dying from these conditions

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