(nelfinavir mesylate)

Prescribing Information
Download Prescribing Information

6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.1 Clinical Trials Experience: Adults and Adolescents (13 years and older)

The safety of VIRACEPT was studied in over 5000 patients who received drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving VIRACEPT was diarrhea, which was generally of mild to moderate intensity.

Drug-related clinical adverse experiences of moderate or severe intensity in ≥2% of patients treated with VIRACEPT coadministered with d4T and 3TC (Study 542) for up to 48 weeks, or with ZDV plus 3TC (Study 511) for up to 24 weeks are presented in Table 4.

Table 4: Percentage of Patients with Treatment-Emergent* Adverse Events of Moderate or Severe Intensity Reported in ≥ 2% of Adult and Adolescent Patients
Study 511Study 542
24 weeks48 weeks
 
Adverse Events		Placebo
+ ZDV/3TC
(n=101)		500 mg TID VIRACEPT +
ZDV/3TC
(n=97)		750 mg TID VIRACEPT + ZDV/3TC
(n=100)		1250 mg BID VIRACEPT + d4T/3TC
(n=344)		750 mg TID VIRACEPT + d4T/3TC
(n=210)
*
Includes those adverse events at least possibly, probably or definitely related to study drug or of unknown relationship and excludes concurrent HIV conditions

Digestive System

    Diarrhea

3%

14%

20%

20%

15%

    Nausea

4%

3%

7%

3%

3%

    Flatulence

0

5%

2%

1%

1%

Skin/Appendages

    Rash

1%

1%

3%

2%

1%

Adverse events occurring in less than 2% of patients receiving VIRACEPT in all phase 2 and 3 clinical trials and considered at least possibly related or of unknown relationship to treatment and of at least moderate severity are listed below.

Body as a Whole: abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain, and redistribution/accumulation of body fat [see Warnings and Precautions (5.7)].

Digestive System: anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis, and vomiting.

Hemic/Lymphatic System: anemia, leukopenia, and thrombocytopenia.

Metabolic/Nutritional System: increases in alkaline phosphatase, amylase, creatine phosphokinase, lactic dehydrogenase, SGOT, SGPT, and gamma-glutamyl transpeptidase; hyperlipemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, and liver function tests abnormal.

Musculoskeletal System: arthralgia, arthritis, cramps, myalgia, myasthenia, and myopathy.

Nervous System: anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, somnolence, and suicide ideation.

Respiratory System: dyspnea, pharyngitis, rhinitis, and sinusitis.

Skin/Appendages: dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, and urticaria.

Special Senses: acute iritis and eye disorder.

Urogenital System: kidney calculus, sexual dysfunction, and urine abnormality.

Laboratory Abnormalities

The percentage of patients with marked laboratory abnormalities in Studies 542 and 511 are presented in Table 5. Marked laboratory abnormalities are defined as a Grade 3 or 4 abnormality in a patient with a normal baseline value, or a Grade 4 abnormality in a patient with a Grade 1 abnormality at baseline.

Table 5: Percentage of Patients by Treatment Group with Marked Laboratory Abnormalities* in >2% of Patients
Study 511Study 542
Placebo + ZDV/3TC
(n=101)		500 mg TID VIRACEPT +
ZDV/3TC
(n=97)		750 mg TID VIRACEPT + ZDV/3TC
(n=100)		1250 mg BID VIRACEPT + d4T/3TC
(n=344)		750 mg TID VIRACEPT + d4T/3TC
(n=210)
*
Marked laboratory abnormalities are defined as a shift from Grade 0 at baseline to at least Grade 3 or from Grade 1 to Grade 4

Hematology

    Hemoglobin

6%

3%

2%

0

0

    Neutrophils

4%

3%

5%

2%

1%

    Lymphocytes

1%

6%

1%

1%

0

Chemistry

    ALT (SGPT)

6%

1%

1%

2%

1%

    AST (SGOT)

4%

1%

0

2%

1%

    Creatine Kinase

7%

2%

2%

NA

NA

6.2 Clinical Trials Experience: Pediatrics (2 to less than 13 years of age)

VIRACEPT has been studied in approximately 400 pediatric patients in clinical trials from birth to 13 years of age. The adverse event profile seen during pediatric clinical trials was similar to that for adults.

The most commonly reported drug-related, treatment-emergent adverse events reported in the pediatric studies included: diarrhea, leukopenia/neutropenia, rash, anorexia, and abdominal pain. Diarrhea, regardless of assigned relationship to study drug, was reported in 39% to 47% of pediatric patients receiving VIRACEPT in 2 of the larger treatment trials. Leukopenia/neutropenia was the laboratory abnormality most commonly reported as a significant event across the pediatric studies.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIRACEPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever, and edema).

Cardiovascular System: QTc prolongation, torsades de pointes.

Digestive System: jaundice.

Metabolic/Nutritional System: bilirubinemia, metabolic acidosis.

Medication Guide
Download Consumer Medicine Information

MEDICATION GUIDE

PATIENT INFORMATION

VIRACEPT (VI-ra-cept)
(nelfinavir mesylate)
Tablets

VIRACEPT (VI-ra-cept)
(nelfinavir mesylate)
Oral Powder

Important: VIRACEPT can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with VIRACEPT. See the section "Do not take VIRACEPT if you:"

What is VIRACEPT?

VIRACEPT is a prescription HIV-1 medicine used with other HIV-1 medicines to treat human immunodeficiency virus (HIV-1) infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if VIRACEPT is safe and effective in children less than 2 years of age.

Do not take VIRACEPT if you:

•
are taking any of the following medicines. VIRACEPT may cause serious life-threatening side effects or death when used with these medicines:
o
alfuzosin
o
amiodarone
o
cisapride
o
ergot-containing medicines:
▪
dihydroergotamine
▪
ergotamine
▪
methylergonovine
o
lovastatin
o
lurasidone
o
midazolam, when taken by mouth for sedation
o
pimozide
o
quinidine
o
rifampin
o
sildenafil (Revatio®), when used for the treatment of pulmonary arterial hypertension (PAH)
o
simvastatin
o
St. John's wort (Hypericum perforatum)
o
triazolam

Before taking VIRACEPT, tell your healthcare provider about all of your medical conditions, including if you:

•
have liver problems
•
have kidney problems
•
have phenylketonuria. VIRACEPT Oral Powder contains aspartame.
•
have high blood sugar (diabetes)
•
have hemophilia
•
are pregnant or plan to become pregnant. VIRACEPT may harm your unborn baby.
o
Tell your healthcare provider right away if you become pregnant during treatment with VIRACEPT.
o
Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and some birth control pills may not work during treatment with VIRACEPT. Talk to your healthcare provider about forms of birth control that may be used during treatment with VIRACEPT.
o
Pregnancy Registry. There is a pregnancy registry for women who take VIRACEPT during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
•
are breastfeeding or plan to breastfeed. Do not breastfeed if you take VIRACEPT.
o
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
o
VIRACEPT can pass into your breast milk.
o
Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines interact with VIRACEPT. Keep a list of your medicines to show your healthcare provider and pharmacist.

•
You can ask your healthcare provider or pharmacist for a list of medicines that interact with VIRACEPT.
•
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take VIRACEPT with other medicines.
o
Especially tell your healthcare provider if you take medicines that contain didanosine. Take VIRACEPT with food one hour after or more than two hours before you take didanosine.

How should I take VIRACEPT?

•
You should stay under a healthcare provider's care during treatment with VIRACEPT.
•
Take VIRACEPT every day exactly as prescribed by your healthcare provider.
•
Do not change your dose of VIRACEPT or stop treatment without talking to your healthcare provider first.
•
Take VIRACEPT with a meal.
•
VIRACEPT is usually taken 2 or 3 times each day. Your healthcare provider will tell you how much VIRACEPT to take and when to take it.
•
If your child is taking VIRACEPT, your child's healthcare provider will decide the right dose based on your child's weight.
•
VIRACEPT Tablets are film-coated to help make the tablets easier to swallow.
•
If you or your child are unable to swallow the tablets:
o
You may dissolve the tablets in a small amount of water. Once the tablets are dissolved, the liquid will be cloudy.
o
Mix the cloudy liquid well, and then drink it right away.
o
Rinse the glass with water and drink the water to ensure that you take the full dose of VIRACEPT.
•
If you miss a dose of VIRACEPT, take it as soon as possible. If you skip a dose, do not double the next dose.
•
If you take too much VIRACEPT, call your healthcare provider or go to the nearest hospital emergency room right away.
•
Do not run out of VIRACEPT. Get your VIRACEPT refilled from your healthcare provider or pharmacy before you run out.

How should VIRACEPT Oral Powder be prepared?

•
Your healthcare provider should tell you how much VIRACEPT Oral Powder to use.
•
VIRACEPT Oral Powder comes with a scoop for measuring. Ask your healthcare provider or pharmacist for help measuring the correct amount of VIRACEPT Oral Powder.
•
Do not mix VIRACEPT Oral Powder in the container that it comes in. Measure the correct amount of VIRACEPT Oral Powder into a cup.
•
You may mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or liquid dietary supplements.
•
You should not mix VIRACEPT Oral Powder with acidic food or juice, such as orange juice, apple juice, or applesauce because the mixture may taste bitter.
•
Your child should drink all of the mixture to be sure that the entire dose of VIRACEPT is taken.
•
If your child does not take the dose right away, store in the refrigerator until you are ready to use it. Do not store a mixed dose of VIRACEPT Oral Powder for more than 6 hours.

What are the possible side effects of VIRACEPT?

VIRACEPT can cause serious side effects, including:

•
Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including VIRACEPT can get high blood sugar, develop diabetes, or your diabetes can get worse. Some people have had to start taking medicine to treat diabetes or have had to change their diabetes medicine. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking VIRACEPT.
•
Increased bleeding in people with hemophilia. Some people with hemophilia have increased bleeding with protease inhibitors including VIRACEPT.
•
Changes in body fat. These changes can happen in people taking HIV-1 medicines. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
•
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

The most common side effects of VIRACEPT in adults and adolescents (13 years of age and older) include:

•
diarrhea
•
nausea
•
rash
•
gas

The most common side effects of VIRACEPT in children (2 years of age to less than 13 years of age) include:

•
diarrhea
•
low white blood cell count (leukopenia and neutropenia)
•
rash
•
loss of appetite
•
stomach-area (abdominal) pain

These are not all the possible side effects of VIRACEPT.

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

How should I store VIRACEPT?

•
Store VIRACEPT Tablets and Oral Powder at room temperature, between 59ºF to 86ºF (15ºC to 30ºC).
•
Store VIRACEPT in the original container.
•
Keep the container closed tightly.

Keep VIRACEPT and all medicines out of the reach of children.

General information about the safe and effective use of VIRACEPT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VIRACEPT for a condition for which it was not prescribed. Do not give VIRACEPT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VIRACEPT that is written for health professionals.

What are the ingredients in VIRACEPT?

Active ingredient: nelfinavir mesylate

Tablet inactive ingredients: calcium silicate, crospovidone, magnesium stearate, hypromellose, and triacetin. In addition, the 250 mg tablet contains FD&C blue #2 powder and the 625 mg tablet contains colloidal silicon dioxide.

Oral powder inactive ingredients: microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hypromellose, aspartame, sucrose palmitate, and natural and artificial flavor.

Logo


VIRACEPT is a registered trademark of Agouron Pharmaceuticals, LLC

For more information, call 1-800-438-1985.

Trademarks are the property of their respective owners.

LAB-0346-15.0

This Patient Information has been approved by the U.S. Food and Drug Administration.     Revised: 10/2023

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.