Saquinavir

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Chest pain
  • Cough
  • Fever or chills
  • Increased amount of fat in the upper back and neck, or around the chest and stomach area
  • Loss of fat from the legs, arms, and face
  • Shortness of breath
  • Sneezing
  • Sore throat
  • Tightness in the chest
  • Troubled breathing
  • Wheezing

Less common

  • Blurred vision
  • Cough-producing mucus
  • Diarrhea
  • Difficulty with breathing
  • Dry mouth
  • Flushed, dry skin
  • Fruit-like breath odor
  • General feeling of discomfort or illness
  • Headache
  • Increased hunger
  • Increased thirst
  • Increased urination
  • Joint pain
  • Loss of appetite
  • Loss of consciousness
  • Muscle aches and pains
  • Nausea
  • Runny nose
  • Shivering
  • Skin rash
  • Sore throat
  • Stomachache
  • Sweating
  • Trouble sleeping
  • Troubled breathing
  • Unexplained weight loss
  • Unusual tiredness or weakness
  • Vomiting

Rare

  • Burning or prickling sensation
  • Confusion
  • Dehydration
  • Dry or itchy skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Acid or sour stomach
  • Back pain
  • Belching
  • Bloated or full feeling
  • Change in taste
  • Decreased interest in sexual intercourse
  • Difficulty having a bowel movement (stool)
  • Discouragement
  • Excess air or gas in the stomach or intestines
  • Fear
  • Feeling sad or empty
  • Headache
  • Heartburn
  • Inability to have or keep an erection
  • Indigestion
  • Irritability
  • Lack of appetite
  • Loss in sexual ability, desire, drive, or performance
  • Loss of interest or pleasure
  • Mouth ulcers
  • Nervousness
  • Pain or tenderness around the eyes and cheekbones
  • Passing gas
  • Skin rash, encrusted, scaly, and oozing
  • Skin warts
  • Sleeplessness
  • Stomach upset, discomfort, or pain
  • Stuffy nose
  • Tiredness
  • Trouble concentrating
  • Unable to sleep
  • Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not take this medicine if you or your child are also taking medicine for heart rhythm problems (e.g., amiodarone, bepridil, dofetilide, flecainide, lidocaine, propafenone, quinidine, Cordarone®, Pacerone®, Quinora®, Rhythmol®, Tambocor®, Tikosyn®, or Vascor®), ergotamine medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Embolex®, Ergomar®, Ergostate®, Ergotrate®, Methergine®, Migergot®, Migranal®, Wigraine®, or Wigrettes®), medicine to lower cholesterol (e.g., lovastatin, simvastatin, Advicor®, Altoprev®, Mevacor®, Simcor®, Vytorin®, or Zocor®), alfuzosin (Uroxatral®), astemizole (Hismanal®), cisapride (Propulsid®), fluticasone (Flonase®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil (Revatio®), terfenadine (Seldane®), tipranavir (Aptivus®), trazodone (Desyrel®, Oleptro®), or triazolam (Halcion®). Taking any of these together with this medicine may increase the chance for serious side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John’s wort, garlic capsules) or vitamin supplements.

This medicine may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control together with your pills, such as condoms, diaphragms, or contraceptive foams or jellies.

This medicine can cause changes in heart rhythms, such as a condition called PR or QT interval prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Saquinavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor right away.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

It is important that this medicine be taken with food in order to work properly. Take saquinavir within 2 hours after a meal.

Saquinavir capsules or tablets (Invirase®) should always be taken together, at the same time, with ritonavir (Norvir®). Take all other medicines your doctor has prescribed at the right time of the day. This will make your medicines work better.

Keep taking saquinavir for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, take this medicine at the same time each day and do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed especially for you. Do not share your medicine with others.

Read and carefully follow the Medication Guide and patient information leaflet before starting saquinavir treatment and each time you get a refill. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of HIV infection:
    • For oral dosage form (capsules or tablets):
      • Taken in combination with ritonavir (Norvir®):
        • Adults and teenagers 16 years of age and older—1000 milligrams (mg) (5 capsules or 2 tablets) of saquinavir and 100 mg of ritonavir two times per day.
        • Children younger than 16 years of age—Use and dose must be determined by your doctor.
      • Taken in combination with lopinavir/ritonavir (Kaletra®):
        • Adults and teenagers 16 years of age and older—1000 milligrams (mg) (5 capsules or 2 tablets) of saquinavir and 400 mg of lopinavir plus 100 mg of ritonavir two times per day.
        • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of saquinavir in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saquinavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving saquinavir.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Amiodarone
  • Astemizole
  • Bepridil
  • Cisapride
  • Colchicine
  • Crizotinib
  • Dihydroergotamine
  • Dofetilide
  • Dronedarone
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Flecainide
  • Lidocaine
  • Lovastatin
  • Mesoridazine
  • Methylergonovine
  • Midazolam
  • Pimozide
  • Posaconazole
  • Propafenone
  • Quinidine
  • Ranolazine
  • Rifampin
  • Sildenafil
  • Silodosin
  • Simvastatin
  • Sorafenib
  • Terfenadine
  • Thioridazine
  • Tolvaptan
  • Trazodone
  • Triazolam
  • Vandetanib
  • Vemurafenib
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Amprenavir
  • Atazanavir
  • Bosentan
  • Brentuximab Vedotin
  • Cabazitaxel
  • Chlorpromazine
  • Clarithromycin
  • Clozapine
  • Darunavir
  • Dasatinib
  • Digoxin
  • Docetaxel
  • Eplerenone
  • Erythromycin
  • Everolimus
  • Fluphenazine
  • Fluticasone
  • Fosamprenavir
  • Fusidic Acid
  • Garlic
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Ixabepilone
  • Lapatinib
  • Loperamide
  • Lopinavir
  • Methadone
  • Nilotinib
  • Oxycodone
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Rifabutin
  • Rivaroxaban
  • Romidepsin
  • Salmeterol
  • Sirolimus
  • Sotalol
  • St John’s Wort
  • Sunitinib
  • Tadalafil
  • Tamsulosin
  • Temsirolimus
  • Ticagrelor
  • Tipranavir
  • Topotecan
  • Toremifene
  • Trifluoperazine
  • Triflupromazine
  • Vardenafil
  • Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Atorvastatin
  • Cerivastatin
  • Cimetidine
  • Cyclosporine
  • Dapsone
  • Delavirdine
  • Efavirenz
  • Fentanyl
  • Fluconazole
  • Flunarizine
  • Fosphenytoin
  • Gallopamil
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lacidipine
  • Maraviroc
  • Nelfinavir
  • Nevirapine
  • Nilvadipine
  • Nitrendipine
  • Omeprazole
  • Rifapentine
  • Tacrolimus
  • Voriconazole
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcoholism, history of or
  • Liver disease or
  • Diabetes or
  • Hemophilia (a bleeding problem) or
  • Hyperglycemia (high blood sugar) or
  • Hyperlipidemia (high cholesterol or fat in the blood) or
  • Liver disease (e.g., hepatitis B or C)—Use with caution. May increase your chance for serious side effects.
  • Heart block without a pacemaker or
  • Heart rhythm problems (e.g., congenital long QT syndrome) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Liver disease, severe—Should not be used in patients with these conditions.
  • Heart disease (e.g., cardiomyopathy, ischemia, congestive heart failure), history of or
  • Heart rhythm problems (e.g., arrhythmias, prolonged PR or QT interval), history of—Use with caution. May increase risk for more serious side effects.
  • Lactose intolerance—Use with caution. Saquinavir capsules contain lactose.

Description

Saquinavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Saquinavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease from occurring. Saquinavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor’s prescription.