Pronunciation:

al-pe-LIS-ib

Brand Names:

• Piqray 200MG Daily Dose
• Piqray 250MG Daily Dose
• Piqray 300MG Daily Dose
• Vijoice

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Alpelisib is used together with other medicines (eg, fulvestrant) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA­mutated, advanced or metastatic (cancer that has spread) breast cancer in men and in women who have already stopped menstruating (postmenopausal). Your doctor will test for the presence of the mutation.

Alpelisib is also used to treat PIK3CA-related overgrowth spectrum (PROS). PROS is a group of rare conditions that cause body parts to grow too much or have an unusual shape.

Alpelisib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of alpelisib to treat breast cancer in children and to treat PIK3CA-related overgrowth spectrum (PROS) in children younger than 2 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Piqray® tablets in the elderly.

Appropriate studies on the relationship of age to the effects of Vijoice® tablets have not been performed in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

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.

Other medicines—

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 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.

• Apalutamide
• Carbamazepine
• Darolutamide
• Eltrombopag
• Enzalutamide
• Fosphenytoin
• Lumacaftor
• Mitotane
• Phenytoin
• Rifampin
• St John's Wort
• Velpatasvir
• Voxilaprevir

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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
• Lung disease or breathing problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the medicine with food at about the same time each day.

Swallow the tablet whole. Do not crush, break, or chew it. Do not take this medicine if it is broken, cracked, or damaged.

If you cannot swallow Vijoice® tablets:

• Mix the tablets into a glass with 2 to 4 ounces of water and let it stand for at least 5 minutes. Use water only.
• Crush the tablets with a spoon and stir to dissolve. The mixture will be cloudy and you may still see some tablet pieces.
• Swallow the mixture right away.
• Add 2 to 3 tablespoons of water to the same glass and stir with the same spoon. Swallow the entire contents of the glass to make sure you get the full dose. Repeat this step if needed.

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 form (tablets):
  • For breast cancer:
    • Adults—300 milligrams (mg) (two 150 mg tablets) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For PIK3CA-related overgrowth spectrum (PROS):
    • Adults—250 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children 6 years of age and older—At first, 50 mg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 125 mg once a day.
    • Children 2 to younger than 6 years of age—50 mg once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine and it is within 9 hours after the usual time, take it as soon as you can. Then go back to your regular schedule. If you miss a dose and it is more than 9 hours since your usual time, skip the missed dose and go back to your regular dosing schedule.

If you vomit after you take this medicine, do not take another dose the same day. Wait and take your next dose when you normally would.

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.

Throw away any unused mixture of Vijoice® after 60 minutes of mixing it.

Precautions While Using This Medicine:

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

It is unlikely that a postmenopausal woman may become pregnant. But, using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, and anaphylactic shock, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

This medicine may cause diarrhea (colitis), and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration and kidney problems. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor. Call your doctor right away if you have stomach pain, or mucus or blood in your stool.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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 or vitamin supplements.

Side Effects of This Medicine:

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

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

diarrhea

difficult, burning, or painful urination

dry mouth

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

increased hunger

increased thirst

increased urination

lower back or side pain

nausea

rapid weight gain

stomach pain

sweating

tingling of the hands or feet

trouble breathing

unexplained weight loss

unusual tiredness of weakness

unusual weight gain or loss

vomiting

Less common

Pale skin

unusual bleeding or bruising

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

chest pain

chills

cough

itching

joint or muscle pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

painful or difficult urination

red irritated eyes

red skin lesions, often with a purple center

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

unusual bleeding or bruising

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

Belching

decreased weight

dry skin or mouth

hair loss or thinning of hair

headache

heartburn

indigestion

loss or change in taste

stomach discomfort or upset

swelling or inflammation of the mouth

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.