Description
Nelfinavir is usually used in combination with other medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Nelfinavir 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 related to AIDS or HIV disease. Nelfinavir 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.
This product is available in the following dosage forms:
- Tablet
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nelfinavir in children 2 years of age or older. However, safety and efficacy have not been established in children younger than 2 years of age.
Geriatric
Appropriate studies on the relationship of age to the effects of nelfinavir have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
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
- Astemizole
- Atazanavir
- Bedaquiline
- Bepridil
- Cisapride
- Citalopram
- Clarithromycin
- Clozapine
- Colchicine
- Conivaptan
- Crizotinib
- Dasatinib
- Dihydroergotamine
- Dronedarone
- Eletriptan
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Haloperidol
- Iloperidone
- Isavuconazonium Sulfate
- Itraconazole
- Ivabradine
- Lapatinib
- Levoketoconazole
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lumefantrine
- Lurasidone
- Mavacamten
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
- Amisulpride
- Anagrelide
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Atidarsagene Autotemcel
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azithromycin
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosutinib
- Brentuximab Vedotin
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Budesonide
- Buprenorphine
- Bupropion
- Buserelin
- Cabazitaxel
- Cabotegravir
- Cabozantinib
- Calcifediol
- Capivasertib
- Carbamazepine
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
- Amprenavir
- Cobicistat
- Delavirdine
- Didanosine
- Felodipine
- Fosphenytoin
- Lopinavir
- Phenytoin
- Pravastatin
- Zidovudine
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:
- Diabetes or
- Hemophilia (bleeding disorder) or
- Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.
- Liver disease, moderate or severe—Should not be used in patients with this condition.
- Phenylketonuria (PKU) (a metabolic disease)—The oral powder form contains phenylalanine, which may cause a problem for patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. 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 first checking with your doctor. Keep taking nelfinavir for the full time of treatment, even if you begin to feel better.
It is important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully before starting treatment and each time you refill your prescription. Ask your doctor if you have any questions.
Nelfinavir works best if it is taken with food.
If you are also using didanosine (Videx®), take it 1 hour before or at least 2 hours after taking nelfinavir.
If you cannot swallow the tablet whole, you may dissolve it in a small amount of water. Be sure to drink or swallow the entire mixture right away. Then refill the glass with water and drink it so none of the medicine is left on the sides of the glass.
Measure the powder carefully using the measuring scoop provided with the medicine. Mix the powder with a small amount of water, milk, soy milk, baby formula, or a dietary supplement drink. Do not use apple juice, orange juice, or apple sauce. After mixing your medicine with a liquid, use the mixture right away. Be sure to drink or swallow all of the mixture. If not used right away, you may store this mixture in the refrigerator for up to 6 hours.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. For example, if you are to take three doses each 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.
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 (oral powder):
- Children 2 to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 45 to 55 milligrams per kilogram (mg/kg) of body weight 2 times a day or 25 to 35 mg per kg of body weight 3 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 13 years and older—1250 milligrams (mg) (five 250 mg tablets or two 625 mg tablets) 2 times a day or 750 mg (three 250 mg tablets) 3 times a day.
- Children 2 to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 45 to 55 milligrams per kilogram (mg/kg) of body weight 2 times a day or 25 to 35 mg per kg of body weight 3 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (oral powder):
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
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.
Precautions
If you will be taking this medicine for a long time, 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.
Do not use this medicine if you are also using alfuzosin (Uroxatral®), amiodarone Cordarone®), lovastatin (Advicor®, Altocor®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), quinidine (Quinaglute®), rifampin (Rifadin®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, DHE 45®, Ergomar®),
Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may increase blood sugar levels. Check with your doctor right away if you or your child notice a change in the results of your blood or urine sugar tests, or if you have confusion, nausea or vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, including an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
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 (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
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 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 and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) 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:
Less common
- Anxiety
- bleeding gums
- bloating
- blood in the urine or stools
- bloody, black, tarry stools
- blurred vision
- chest pain
- chills
- coma
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- dehydration
- dizziness
- dry mouth
- fast heartbeat
- fever
- flushed, dry skin
- fruity mouth odor
- increased hunger
- increased thirst
- increased urination
- indigestion
- joint pain, stiffness, or swelling
- loss of appetite
- nausea
- nervousness
- nightmares
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- seizures
- shakiness
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- swelling of the feet or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
- weight loss
Incidence not known
- Clay-colored stools
- difficulty with breathing
- drowsiness
- fainting
- headache
- irregular heartbeat
- muscle tremors
- noisy breathing
- rapid, deep breathing
- recurrent fainting
- restlessness
- skin rash
- unpleasant breath odor
- vomiting of blood
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:
More common
- Diarrhea
Less common
- Acid or sour stomach
- belching
- burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
- difficulty in moving
- discouragement
- feeling sad or empty
- heartburn
- increase in body movements
- irritability
- loss of interest or pleasure
- muscle aches, cramps, pain, or stiffness
- muscular tenderness, wasting or weakness
- passing gas
- redistribution or accumulation of body fat
- sleepiness or unusual drowsiness
- trouble concentrating
- trouble sleeping
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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