Viracept 625 mg tablet

Generic name:
Nelfinavir - oral

Pronunciation
(nell-FIN-uh-veer)

Brand name(s)
Viracept

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Nelfinavir belongs to a class of drugs known as protease inhibitors.

Nelfinavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Read the Patient Information Leaflet if available from your pharmacist before you start using nelfinavir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a meal as directed by your doctor, usually 2 to 3 times daily.

If you are unable to swallow tablets, you may crush your dose and take it with food. The tablets may also be dissolved in a small amount of water. If dissolved in water, stir the mixture well and drink all of it right away. Rinse your container with more water and drink the rinse liquid to be sure you receive the entire dose. Do not mix with acidic food or juices (such as orange juice, apple juice/sauce) since this may make the medicine taste bitter.

The dosage is based on your weight, medical condition, other medications, and response to treatment.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat, or worsen side effects.

Diarrhea is a common side effect of this medication. If you have diarrhea, ask your doctor or pharmacist about ways to lessen this side effect, such as using anti-diarrhea medicine. Nausea or gas may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
• signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)

Get medical help right away if you have any very serious side effects, including:

• nausea/vomiting that doesn't stop
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• easy bruising/bleeding
• stomach/abdominal pain
• dark urine
• yellowing eyes/skin

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking nelfinavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• heart problems (coronary artery disease, heart attack)
• lipid problems (high cholesterol or triglycerides/fats)
• hemophilia
• liver problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially diarrhea or rash.

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Breast milk may also transmit HIV. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• orlistat
• certain drugs to lower acid in the stomach (proton pump inhibitors such as lansoprazole, omeprazole)

Nelfinavir can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfuzosin, certain antiarrhythmics (amiodarone, quinidine), asunaprevir, certain benzodiazepines (midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), isavuconazonium, lurasidone, naloxegol, pimozide, ranolazine, regorafenib, tacrolimus, drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), salmeterol, certain "statin" cholesterol drugs (lovastatin, simvastatin), suvorexant, among others.

Other medications can affect the removal of nelfinavir from your body, which may affect how nelfinavir works. Examples include apalutamide, certain anti-seizure drugs (carbamazepine, phenobarbital, primidone), rifampin, St. John's wort, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, viral load, T-cell counts, triglycerides/cholesterol, blood sugar) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.