Saquinavir Mesylate (sa-KWIN-a-vir MES-i-late)

Treats HIV infection. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Invirase

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should always be taken together with ritonavir. Take all other medicines your doctor has prescribed at the right time. This will help your medicines work better.
• Take this medicine within 2 hours after a meal.
• Tablets: Do not crush the tablet.
• Do not stop using this medicine without first checking with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply of medicine is running low so you do not run out.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using any of the following:
  • Alfuzosin, atazanavir, cisapride, cobicistat, dapsone, dasatinib, lovastatin, oral midazolam, rifampin, sildenafil, simvastatin, sunitinib, tacrolimus, trazodone, triazolam
  • Ergot medicine (including dihydroergotamine, ergonovine, ergotamine, methylergonovine)
  • Medicine for heart rhythm problems (including amiodarone, bepridil, disopyramide, dofetilide, flecainide, lidocaine, propafenone, quinidine)
  • Medicine to treat an infection (including clarithromycin, erythromycin, halofantrine, pentamidine, quinine)
  • Medicine to treat mental illness (including lurasidone, clozapine, haloperidol, pimozide, sertindole, ziprasidone)
  • Phenothiazine medicine (including chlorpromazine, thioridazine)
• Do not use this medicine together with rilpivirine. Do not switch rilpivirine to saquinavir/ritonavir without a washout period of at least 2 weeks.
• Many other drugs can interact with saquinavir. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease (including hepatitis), diabetes, high cholesterol, or hemophilia. Tell your doctor about all heart conditions you have, including heart failure, heart block, or heart rhythm problems (including long QT syndrome). Also tell your doctor if you are lactose intolerant or drink alcohol.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Changes in heart rhythm (including PR or QT prolongation)
  • High cholesterol or triglycerides
  • High blood sugar levels, which could become permanent
  • Liver problems
  • Increased risk of bleeding
  • Serious skin reactions
• Your immune system may get stronger when you start using an HIV medicine. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, slow, or uneven heartbeat, chest pain
• Increased hunger or thirst, change in how much or how often you urinate, unusual weight loss
• Sudden and severe stomach pain, fever
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Tiredness
• Weight gain around your neck, upper back, breast, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088