Description
Galcanezumab-gnlm injection is used to prevent migraine headaches. It is also used to treat cluster headache, a form of headache that produces extreme pain and usually occurs in clusters, often at the same time(s) of the day, for several weeks to months.
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 galcanezumab-gnlm 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 galcanezumab-gnlm 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, upper arm, or buttocks. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the 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, or hard.
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 syringe and a prefilled pen. Before you inject this medicine, always check the label of the device to make sure you have the correct medicine and the correct dose.
Check the liquid in the prefilled syringe or pen. It should be clear and colorless to slightly yellow or slightly brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake. Do not use it if it looks damaged.
Allow 30 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (eg, hot water, microwave, direct sunlight) or in any other way.
To use the prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Twist off the base cap and throw it away. Do not put it back on. Do not touch the needle.
- Place and hold the clear base flat and firmly against your skin. Turn the lock ring to the unlock position. Press and hold the teal injection button, you will hear a loud "click". Keep holding the clear base firmly. You will hear a second "click" in about 10 seconds after the first one. This will tell you that you have received 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 off. Do not put it back on. Do not touch the needle.
- Gently pinch and hold a fold of your skin. Insert the needle at a 45 degree angle. Slowly push on the thumb pad to push the plunger all the way down until all the medicine is injected.
- The gray syringe plunger should be pushed all the way down. You should see the plunger rod show through the syringe body when injection is complete.
You might not use all of the medicine in each prefilled syringe or pen. Use each prefilled syringe and pen only one time. Do not save an open syringe or pen.
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 (solution):
- For episodic cluster headaches:
- Adults—At first, 300 milligrams (mg) injected under the skin (given as three 100 mg injections in a row) at the start of a cluster headache. Then 300 mg injected under the skin once a month until the end of the cluster period.
- Children—Use and dose must be determined by your doctor.
- For migraine headaches:
- Adults—At first, 240 milligrams (mg) injected under the skin as a loading dose (given as two 120 mg injections in a row). This is followed by 120 mg injected under the skin once a month.
- Children—Use and dose must be determined by your doctor.
- For episodic cluster 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. If you have missed a dose of this medicine and you are using it for episodic cluster headaches, continue to use this medicine each month from the date of your last dose until the end of the cluster period.
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 also store it at room temperature for up to 7 days. Do not place it back in the refrigerator once you store it at room temperature.
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 decide if you should continue to receive it. Blood tests will be needed 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
- difficulty breathing
- dizziness
- fast heartbeat
- fever
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- nervousness
- paleness or cold feeling in the fingertips and toes
- pounding in the ears
- redness of the skin
- slow or fast heartbeat
- swelling of the eyelids, face, lips, hands, or feet
- tingling or pain in the fingers or toes when exposed to cold
- trouble with swallowing
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.
CON-XXXXXXXX
