Pronunciation:

ven-ET-oh-klax

Brand Names:

• Venclexta

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Venetoclax is used alone or together with other medicines (eg, rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, in patients who have received at least one previous treatment. It is also used together with obinutuzumab to treat previously untreated CLL or SLL.

Venetoclax is also used together with other medicines (eg, azacitidine, decitabine, low-dose cytarabine) to treat newly-diagnosed acute myeloid leukemia (AML) in adults 75 years of age and older or who have other medical conditions that prevent the use of standard chemotherapy.

Venetoclax is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

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 venetoclax in the pediatric population. 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 venetoclax in the elderly. Safety and efficacy have 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

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.

• Adagrasib
• Aliskiren
• Amiodarone
• Aprepitant
• Atazanavir
• Berotralstat
• Betrixaban
• Bosentan
• Capmatinib
• Carbamazepine
• Carvedilol
• Ciprofloxacin
• Colchicine
• Crizotinib
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Digoxin
• Diltiazem
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Duvelisib
• Efavirenz
• Elagolix
• Enzalutamide
• Erythromycin
• Everolimus
• Fedratinib
• Fexinidazole
• Fexofenadine
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Glecaprevir
• Imatinib
• Ivosidenib
• Lapatinib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Letermovir
• Loperamide
• Lorlatinib
• Maraviroc
• Mavacamten
• Mitotane
• Modafinil
• Nafcillin
• Naldemedine
• Netupitant
• Nilotinib
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Phenytoin
• Pibrentasvir
• Pirtobrutinib
• Primidone
• Quinidine
• Ranolazine
• Repotrectinib
• Rifampin
• Ritlecitinib
• Sirolimus
• St John's Wort
• Talazoparib
• Tolvaptan
• Topotecan
• Trofinetide
• Vemurafenib
• Verapamil
• Voxilaprevir

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.

• Warfarin

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange
• Grapefruit Juice
• Starfruit

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:

• Gout or
• Hyperuricemia (high uric acid in the blood), history of or
• Kidney disease—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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. Do not change your dose or stop using this medicine without first asking your doctor.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food and water at the same time each day. Swallow the tablet whole. Do not break, crush, or chew it.

Drink plenty of water each day to help prevent an unwanted effect called tumor lysis syndrome. Your doctor may also give medicine to decrease uric acid in the blood (eg, allopurinol).

Do not eat or drink grapefruit products, starfruit, or Seville oranges with this medicine.

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 acute myeloid leukemia:
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor will gradually increase your dose each week. However, the dose is usually not more than 400 mg per day when given with azacitidine or decitabine or not more than 600 mg per day when given with low-dose cytarabine.
    • Children—Use and dose must be determined by your doctor.
  • For chronic lymphocytic leukemia or small lymphocytic lymphoma:
    • Adults—At first, 20 milligrams (mg) once a day. Your doctor will gradually increase your dose each week for 5 weeks (ramp-up). However, the dose is usually not more than 400 mg per day.
    • Children—Use and dose must be determined by your doctor.

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.

If you miss a dose and it is 8 hours or less after your normal time, take it as soon as you can and continue with your regular schedule. If it is more than 8 hours after your normal time, skip the missed dose and return to your regular dosing schedule.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the usual time the following day.

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 tablets in the original package during the first 4 weeks of treatment. Do not transfer the medicine to a pillbox or another container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women must have a negative pregnancy test before starting this medicine. Use an effective form of birth control during treatment and for at least 30 days after the last dose to prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not use this medicine together with clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, posaconazole, ritonavir, telaprevir, and voriconazole. Using these medicines together may cause serious unwanted effects.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may cause serious infections, including pneumonia (lung infection) and sepsis (blood infection), which can be life-threatening. Check with your doctor if you have symptoms of an infection such as a fever, chills, body aches, or sore throat. This medicine may decrease the amount of white blood cells in the blood. White blood cells help your immune system fight infections. Avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured.

While you are being treated with venetoclax, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Venetoclax may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine may 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 (eg, St. John's wort) 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

Black, tarry stools

bladder pain

bleeding gums

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

blood in the urine or stools

blurred vision

body aches or pain

bone pain

chest pain or tightness

chills

cloudy urine

confusion

cough

coughing up blood

decreased urine

difficult, burning, or painful urination

difficulty in breathing or swallowing

difficulty in moving

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

fainting

fever

frequent urge to urinate

headache

increased menstrual flow or vaginal bleeding

increased thirst

itching, pain, redness, swelling, tenderness, or warmth on the skin

joint pain, stiffness, or swelling

lightheadedness

loss of appetite

lower back or side pain

mood or mental changes

muscle cramps, pains, or stiffness

muscle spasms (tetany) or twitching seizures

nausea

nervousness

nosebleeds

numbness or tingling in the hands, feet, or lips

pale skin

paralysis

pinpoint red spots on the skin

pounding in the ears

prolonged bleeding from cuts

rapid weight gain

rapid, shallow breathing

red or black, tarry stools

red or dark brown urine

seizures

slow, fast, or irregular heartbeat

sneezing

sore throat

tingling of the hands or feet

trembling

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

yellow eyes or skin

Less common

Diarrhea

holding false beliefs that cannot be changed by fact

irritability

restlessness

seeing, hearing, or feeling things that are not there

unusual excitement, nervousness, or restlessness

Incidence not known

Ear congestion

runny or stuffy nose

stomach pain

ulcers, sores, or white spots in the mouth

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

Back pain

decreased appetite

difficulty having a bowel movement

mouth or throat pain

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.