Description
Talquetamab-tgvs injection is used to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma in patients who have received at least 4 previous treatments. These previous treatments include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This medicine is available only under a restricted distribution program called Tecvayli™ and Talvey™ REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Solution
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 talquetamab-tgvs injection 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 talquetamab-tgvs injection 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Serious infection—Use with caution. May make this condition worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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.
A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as a shot under your skin, usually in the stomach or thigh.
It is very important that you understand the requirements of the Tecvayli™ and Talvey™ REMS program, and become familiar with the Tecvayli™ and Talvey™ medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
You will receive this medicine on a weekly or biweekly (every 2 weeks) "step-up dosing schedule". Weekly dosing schedule: You will receive this medicine on Days 1 and 4, followed by the first treatment dose on Day 7. After you receive your first treatment dose, this medicine is usually given once a week. Biweekly dosing schedule: You will receive this medicine on Days 1, 4, and 7, followed by the first treatment dose on Day 10. After you receive your first treatment dose, this medicine is usually given every 2 weeks. Your doctor will ask you to stay for 48 hours after receiving the step-up doses.
You may also receive other medicines (eg, allergy medicine, fever medicine, steroid) 1 to 3 hours before receiving this medicine to help prevent unwanted reactions to the injection.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
Ask your doctor for a patient wallet card. This card will list the symptoms of cytokine release syndrome and nervous system problems. Carry the card with you at all times during treatment. You will need to show the card to any doctor who treats you.
This medicine may cause mouth problems and weight loss. Check with your doctor right away if you have change or loss of taste, difficulty swallowing, dry mouth, or swelling or inflammation of the mouth.
This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, 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. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause serious liver problems. Check with your doctor right away if you have clay colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may cause serious skin reactions (eg, rash, maculopapular rash, erythema, and erythematous rash). Check with your doctor right away if you have flushing, redness of the skin, rash with flat lesions or small raised lesions on the skin, or unusually warm skin.
This medicine may cause dizziness, confusion, sleepiness, or tremors. Do not drive or do anything else that could be dangerous during and for 48 hours after receiving this medicine until you know how this medicine affects you.
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 or nurse immediately if any of the following side effects occur:
More common
- Agitation
- back pain
- being forgetful
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- coma
- confusion
- confusion as to time, place, or person
- cough or hoarseness
- diarrhea
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- ear congestion
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- hallucinations
- headache
- holding false beliefs that cannot be changed by fact
- increased sensitivity to pain
- increased sensitivity to touch
- irritability
- itching of the vagina or genitals
- lightheadedness
- loss of memory
- loss of smell
- loss of voice
- lower back or side pain
- mood or mental changes
- muscle or bone pain
- muscle spasms
- nausea
- nerve pain
- painful or difficulty urination
- problems with memory
- rapid or irregular heartbeat
- rash with flat lesions or small raised lesions on the skin
- seizures
- shakiness in the legs, arms, hands, or feet
- sneezing
- sore throat
- stiff muscles
- stiff neck
- stuffy or runny nose
- sweating
- swelling
- thick, white vaginal discharge with mild or no odor
- tingling in the hands and feet
- trembling and shaking of the hands or feet
- trouble breathing
- unsteadiness or awkwardness
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- vomiting
- weakness in arms, hands, legs, or feet
- weight loss
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
Less common
- Black, tarry stools
- pale skin
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
Incidence not known
- Bleeding gums
- burning, throbbing, or stabbing pain
- dark urine
- double vision
- hearing loss
- jerking movements
- pinpoint red spots on the skin
- rigid muscles
- stomach pain, severe
- trouble speaking
- yellow eyes or skin
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
- Change or loss of taste
- constipation
- decreased appetite
- difficulty swallowing
- dry mouth
- loss of sense of taste
- reduced or lessening or loss of sense of taste
- 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.
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