Description
Saquinavir is used together with ritonavir (Norvir®) and other antiviral medicines for the treatment of human immunodeficiency virus (HIV) infection. 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 slows the destruction of the immune system. This may help delay problems related to AIDS or HIV disease from occurring. Saquinavir will not keep you from spreading HIV to other people.
This medicine (tablet) is available only with your doctor's prescription. The capsules are not currently being marketed.
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 16 years of age and younger. 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.
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
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Bepridil
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Clarithromycin
- Clofazimine
- Clothiapine
- Clozapine
- Colchicine
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Dihydroergotamine
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.
- Abametapir
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Alfentanil
- Amprenavir
- Apalutamide
- Aprepitant
- Asciminib
- Atidarsagene Autotemcel
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosentan
- Bosutinib
- Brentuximab Vedotin
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Budesonide
- Cabazitaxel
- Cabotegravir
- Cabozantinib
- Calcifediol
- Capivasertib
- Carbamazepine
- Cariprazine
- Cilostazol
- Citalopram
- Clomipramine
- Cobicistat
- Cobimetinib
- Codeine
- Copanlisib
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.
- Amlodipine
- Cerivastatin
- Cimetidine
- Flunarizine
- Gallopamil
- Lacidipine
- Nilvadipine
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
- Arrhythmia (abnormal heart beat), history of or
- Congestive heart failure, history of or
- Heart disease, history of or
- Heart rhythm problems, history of or
- Hemophilia (a bleeding problem) or
- Hyperlipidemia (high cholesterol in the blood) or
- Liver disease (eg, hepatitis B or C)—Use with caution. May increase your chance for serious side effects.
- Diabetes or
- Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.
- Galactose intolerance (rare hereditary problem) or
- Glucose-galactose malabsorption (rare hereditary problem) or
- Lapp lactase deficiency (rare hereditary problem) or
- Lactose intolerance—Use is not recommended. Saquinavir contains lactose (milk sugar), which can make these conditions worse.
- Heart block, without a pacemaker or
- Heart rhythm problems (eg, congenital long QT syndrome), history of or
- Liver disease, severe—Should not be used in patients with these conditions.
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 using this medicine without checking first with your doctor.
This medicine should come with a Medication Guide. Read and carefully follow the instructions before starting treatment and each time you get a refill. Ask your doctor or pharmacist if you have any questions.
It is important that this medicine be taken with food. Take it within 2 hours after a meal.
Saquinavir (Invirase®) should always be taken together, and at the same time, with ritonavir (Norvir®). Take all other medicines your doctor has prescribed at the right time of day.
Do not crush the tablets.
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 oral dosage forms ( tablets):
- For treatment of HIV infection:
- For patients who have not taken HIV medicines:
- Adults and children older than 16 years of age—At first, 500 milligrams (mg) with ritonavir 100 mg 2 times a day for the first 7 days. Then, your doctor will increase your dose to 1000 mg with ritonavir 100 mg 2 times a day.
- Children 16 years of age and younger—Use and dose must be determined by your doctor.
- For patients switching from another ritonavir or NNRTI-containing regimen (not including delavirdine or rilpivirine):
- Adults and children older than 16 years of age—At first, 1000 milligrams (mg) (2 tablets) taken with ritonavir 100 mg 2 times a day.
- Children 16 years of age and younger—Use and dose must be determined by your doctor.
- For patients switching from delavirdine or rilpivirine-containing regimen:
- Adults and children older than 16 years of age—At first, 500 milligrams (mg) with ritonavir 100 mg 2 times a day for the first 7 days.
- Children 16 years of age and younger—Use and dose must be determined by your doctor.
- For patients who have not taken HIV medicines:
- For treatment of HIV infection:
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.
Precautions
It is very important that your doctor check your and your child's progress 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 are also using alfuzosin (Uroxatral®), atazanavir (Reyataz®), cisapride (Propulsid®), clozapine (Clozaril®), dapsone, dasatinib (Sprycel®), haloperidol (Haldol®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), quinine, rifampin (Rifadin®), sertindole, sildenafil (Revatio®), sunitinib (Sutent®), tacrolimus (Prograf®), trazodone (Desyrel®, Oleptro®), triazolam (Halcion®), ziprasidone (Geodon®), ergotamine medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®), medicine for heart rhythm problems (eg, amiodarone, bepridil, disopyramide, dofetilide, flecainide, lidocaine, propafenone, quinidine, Cordarone®, Tambocor®, Tikosyn®), medicine to lower cholesterol (eg, lovastatin, simvastatin, Advicor®, Altoprev®, Mevacor®, Simcor®, Vytorin®, Zocor®), medicine to treat an infection (eg, clarithromycin, erythromycin, halofantrine, pentamidine, Biaxin®, Nebupent®), or phenothiazine medicines (eg, chlorpromazine, thioridazine, Mellaril®, Thorazine®). Taking any of these together with this medicine may increase the chance for serious side effects.
Do not use this medicine together with rilpivirine (Edurant®). Do not switch rilpivirine to saquinavir/ritonavir without a washout period of at least 2 weeks.
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, a diaphragm, contraceptive foam or jelly.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as PR or QT prolongation.
This medicine may increase blood sugar levels. Diabetic patients should check with their doctor if they notice a change in blood or urine sugar tests.
Check with your doctor right away if you 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.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders, such as Graves' disease, polymyositis, and Guillain-Barré syndrome may also occur.
This medicine may cause you to have excess body fat. Tell your doctor if you 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.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.
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 (eg, St. John's wort, garlic capsules) or vitamin supplements.
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
- chills
- cough
- fever
- 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
- sneezing
- sore throat
- tightness in the chest
- trouble breathing
Less common
- Blurred vision
- cough-producing mucus
- diarrhea
- 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
- 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
- Back pain
- belching
- bloated or full feeling
- change in taste
- decreased interest in sexual intercourse
- difficulty having a bowel movement
- discouragement
- excess air or gas in the stomach or bowels
- 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
- stomach upset, discomfort, or pain
- stuffy nose
- tiredness
- trouble concentrating
- 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.
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