Description
Motixafortide injection is used in combination with a granulocyte-colony stimulating factor or G-CSF (eg, filgrastim) to mobilize hematopoietic stem cells (HSC) for collection and transplantation in patients with multiple myeloma (MM).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for 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 motixafortide 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 motixafortide 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:
- Blood or bone marrow problems (eg, leukemia)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your upper arm, stomach, or thigh.
Your doctor will ask you to stay for 1 hour after receiving this medicine.
Your doctor will give you other medicines (eg, allergy medicine, stomach medicine, medicine for asthma, pain medicine) 30 to 60 minutes before receiving this medicine.
Your doctor will give you filgrastim once a day for 4 days before receiving this medicine.
Precautions
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.
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 8 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching skin, dizziness, lightheadedness, or fainting, feeling of warmth, redness of the face, neck, arms and occasionally, upper chest, nausea, swelling of the face, tongue, or throat, trouble breathing, chest pain, or vomiting after you receive the medicine.
This medicine may cause injection site reactions. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
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
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blurred vision
- chest tightness
- chills
- confusion
- cough
- decreased urine
- difficulty in breathing or swallowing
- dizziness
- dry mouth
- eye pain
- fast heartbeat
- feeling of warmth
- fever
- general feeling of illness
- headache
- increased thirst
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- shakiness in the legs, arms, hands, or feet
- skin itching, rash, or redness
- sore throat
- swelling of the face, throat, or tongue
- trembling or shaking of the hands or feet
- unusual tiredness or weakness
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
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- cracked, dry, scaly skin
- ear swelling
- swelling
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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