Description
Elinzanetant is used to reduce moderate to severe symptoms of menopause, including feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
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 elinzanetant in the pediatric population. Safety and efficacy have not been established. Elinzanetant is not indicated for use in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elinzanetant in the geriatric population.
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 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.
- Abemaciclib
- Acalabrutinib
- Adagrasib
- Alfentanil
- Amprenavir
- Apalutamide
- Aprepitant
- Astemizole
- Atazanavir
- Axitinib
- Berotralstat
- Boceprevir
- Bosentan
- Bosutinib
- Brigatinib
- Carbamazepine
- Cenobamate
- Ceritinib
- Ciprofloxacin
- Cisapride
- Clarithromycin
- Clindamycin
- Clofazimine
- Cobicistat
- Cobimetinib
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Darunavir
- Dasatinib
- Dexamethasone
- Dihydroergotamine
- Diltiazem
- Dipyrone
- Docetaxel
- Dofetilide
- Dronedarone
- Duvelisib
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:
- Kidney disease, end stage (with or without dialysis) or
- Liver disease, moderate to severe—Use is not recommended in patients with these conditions.
- Liver disease or
- Seizures, history of—Use with caution. May make these conditions worse.
Proper Use
Take this medicine only 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 should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine at the same time each day. You may take it with or without food.
Swallow the capsule whole with water. Do not cut, crush, or chew it.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
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 (capsule):
- For moderate to severe hot flashes:
- Adults—120 milligrams (mg) (two 60 mg capsules) once a day at bedtime. For patients taking certain medicines, your doctor may decrease your dose to 60 mg (one capsule) once a day.
- Children—Use is not recommended.
- For moderate to severe hot flashes:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
For patients taking 1 capsule once a day: Partially peel back the foil covering of the blister card to expose only one of the two capsules. Leave the remaining capsule in the blister card until the next dose.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Your doctor will do blood tests to check your liver before you start and 3 months after you start taking this medicine.
It is unlikely that a postmenopausal woman may become pregnant. But you should know that using this medicine while you are pregnant may cause loss of pregnancy or stillbirth. If you 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 during treatment and for 2 weeks after the last dose. If you think you have become pregnant, tell your doctor right away.
This medicine may make you dizzy, drowsy, feeling faint, or spinning feeling. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor right away if you have dark urine, decreased appetite, nausea, pain in the upper stomach, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness.
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
- Dizziness
- headache
- sleepiness
Less common
- Discouragement
- feeling sad or empty
- irritability
- lack of interest or pleasure
- tiredness
- trouble concentrating
- trouble sleeping
Incidence not known
- Dark urine
- feeling of constant movement of self or surroundings
- lack or loss of strength
- lightheadedness
- loss of appetite
- loss of bladder control
- muscle spasm or jerking of all extremities
- nausea or vomiting
- sensation of spinning
- stomach pain
- sudden loss of consciousness
- 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:
Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- diarrhea
- swelling
Rare
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
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-80008536
