Description
Sonrotoclax is used to treat mantle cell lymphoma that has come back or did not respond to previous treatment in patients who have received at least 2 cancer treatments (eg, BTK inhibitor).
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 have not been performed on the relationship of age to the effects of sonrotoclax in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sonrotoclax in the elderly.
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.
- Adagrasib
- Boceprevir
- Ceritinib
- Clarithromycin
- Cobicistat
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lonafarnib
- Mifepristone
- Nefazodone
- Nelfinavir
- Paritaprevir
- Posaconazole
- Ribociclib
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Troleandomycin
- Tucatinib
- Vonoprazan
- 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.
- Amprenavir
- Apalutamide
- Aprepitant
- Atazanavir
- Berotralstat
- Bosentan
- Carbamazepine
- Cenobamate
- Ciprofloxacin
- Clofazimine
- Conivaptan
- Crizotinib
- Dabrafenib
- Darunavir
- Diltiazem
- Dipyrone
- Dronedarone
- Duvelisib
- Efavirenz
- Elagolix
- Encorafenib
- Enzalutamide
- Erythromycin
- Etravirine
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosamprenavir
- Fosnetupitant
- Fosphenytoin
- Imatinib
- Isavuconazole
- Isavuconazonium
- Ivosidenib
- Lefamulin
- Lenacapavir
- Lesinurad
- Letermovir
- Lopinavir
- Lorlatinib
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.
- Grapefruit Juice
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:
- Electrolyte imbalance (eg, high or low levels of calcium, phosphorus, or potassium)—Must be corrected first before starting treatment with this medicine.
- 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.
Proper Use
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 Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food and a whole glass of water at the same time each day. Swallow the tablet whole. Do not break, chew, or crush 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 restart this medicine without asking your doctor. Your doctor will restart your treatment using a blister pack or tablets in a bottle. Do not use leftover blister packs from your previous treatment without asking your doctor.
If you restart this medicine with a new blister pack, your doctor may ask you to start at the beginning of the blister pack (Day 1) or in the middle of the blister pack (Day 4):
- If you are starting on Day 4 of the blister pack:
- Push the tablets from Days 1, 2, and 3 through the back of the blister pack and throw them away.
- Start taking the tablets labeled "Day 4" on the blister pack. Take 2 tablets every day for 4 days.
Do not eat or drink grapefruit products, star fruit, or Seville oranges while using 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 mantle cell lymphoma:
- Adults—At first, 1 milligram (mg) once a day on Days 1 to 3, followed by 2 mg on Days 4 to 7. Your doctor will gradually increase your dose each week for 4 weeks (ramp-up). However, the dose is usually not more than 320 mg per day.
- Children—Use and dose must be determined by your doctor.
- For mantle cell lymphoma:
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. Do not transfer the medicine to a pillbox or another container.
Precautions
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. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before you start using this medicine. 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.
Do not use this medicine together with itraconazole and posaconazole. 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, 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), which can be life-threatening. Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, lower back or side pain, painful or difficult urination, sneezing, sore throat, or trouble breathing. 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.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan 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
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
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- confusion
- cough
- dizziness
- ear congestion
- fainting
- fast heartbeat
- fever or chills
- general feeling of discomfort or illness
- headache
- joint pain, stiffness, or swelling
- lightheadedness
- loss of voice
- lower back, side, or stomach pain
- painful blisters on the trunk of body
- painful or difficult urination
- pale skin
- rapid weight gain
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the feet or lower legs
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness in the arms, hands, legs, or feet
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
- Constipation
- cracked lips
- diarrhea
- difficulty in swallowing
- muscle or bone pain
- nausea
- vomiting
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.
DRG-80011880
