Description
Fremanezumab-vfrm injection is used to prevent migraine headaches.
This medicine is available only with your doctor's prescription.
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 fremanezumab-vfrm 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 fremanezumab-vfrm 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:
- Hypertension (high blood pressure) or
- Raynaud's phenomenon (blood vessel disease), history of—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arm. It may be given at home if patients do not need to be in the hospital or clinic. If you are using this medicine at home, your healthcare provider will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, callused, tattooed, hard, or has scars or stretch marks.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is available in 2 forms: a prefilled autoinjector and a prefilled syringe.
Allow 30 minutes for the autoinjector to warm up to room temperature. Do not warm using heat sources (eg, hot water, microwave, sunlight).
Check the liquid in the prefilled syringe and prefilled autoinjector. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use it if it has been frozen, damaged, or has cracks or leaks. Do not shake.
To use the prefilled autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Hold the autoinjector and pull the protective cap straight off. Do not twist. Throw away the cap. Do not put it back on.
- Place the autoinjector against your skin at a 90 degree angle. Press down and keep holding it against the skin for about 30 seconds. You will hear the first "click" when the injection starts. You will hear a second "click" about 15 seconds after the first one, until the plunger moves to the bottom of the window. Wait for another 10 seconds to make sure you receive the full dose.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Pull the needle cap straight off. Do not twist. Do not put the cap back on.
- Gently pinch the skin. Insert the needle at a 45 to 90 degree angle. Slowly push the plunger all the way down.
You might not use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.
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 injection dosage form (prefilled autoinjector or prefilled syringe):
- For migraine headaches:
- Adults—225 milligrams (mg) injected under the skin once a month, or 675 mg injected under the skin every 3 months.
- Children—Use and dose must be determined by your doctor.
- For migraine headaches:
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.
Continue to use this medicine each month from the date of your last dose.
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 in the refrigerator. Do not freeze.
Keep the medicine in its original carton. You may store it at room temperature for up to 7 days. Do not return it to the refrigerator. Throw the medicine away if it has been left out of the refrigerator for more than 7 days.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat within 7 days after starting treatment with this medicine.
This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.
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:
Incidence not known
- Blurred vision
- chest tightness
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- headache
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nervousness
- paleness or cold feeling in the fingertips and toes
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tingling or pain in the fingers or toes when exposed to cold
- trouble breathing
- 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
- 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
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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