Description
Efgartigimod alfa and hyaluronidase-qvfc combination injection is used to treat a nerve and muscle problem called generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive. This medicine is also used to treat a nerve problem called chronic inflammatory demyelinating polyneuropathy (CIDP).
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 efgartigimod alfa and hyaluronidase-qvfc combination 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 efgartigimod alfa and hyaluronidase-qvfc combination 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:
- Infection, history of—May decrease your body's ability to fight infection.
Proper Use
Vial: A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under your skin in the stomach area. It is usually given once a week for 4 weeks in patients with gMG and once a week in patients with CIDP.
Prefilled syringe: You may also be taught how to give this medicine at home. It is usually given as a shot under the skin of your stomach.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
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 irritated, tender, red, bruised, infected, scarred, or has moles.
This medicine is available in 2 forms: a prefilled syringe or a vial (glass container).
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow the medicine to warm to room temperature for 30 minutes before using it. Do not warm it by using a heat source or in any other way.
- Check the liquid in the syringe. It should be clear to yellowish. Do not use if it is frozen, discolored, or has particles in it. Do not use the syringe if it is cracked, broken, damaged, or if the cap is missing.
- Remove 1 prefilled syringe from the carton and place the remaining prefilled syringes back into the refrigerator for later use.
- Carefully open the safety needle package and remove the needle. Bend the prefilled syringe cap to one side to snap it off. Do not touch the tip of the prefilled syringe.
- Hold the body of the prefilled syringe with one hand and attach the safety needle by twisting it to the right.
- Hold the body of the syringe and pull the cap straight off. Do not recap.
- Pinch the skin. Insert the needle at a 45 to 90 degree angle into the pinched skin.
- Slowly press the thumb pad down all the way until it stops. It will take about 20 to 30 seconds to inject all of the medicine. Pull the needle straight out.
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 syringe):
- For chronic inflammatory demyelinating polyneuropathy (CIDP):
- Adults—1 single-dose prefilled syringe injected under the skin for 20 to 30 seconds once a week. Each injection contains 1000 milligrams (mg) of efgartigimod alfa and 10,000 units of hyaluronidase-qvfc.
- Children—Use and dose must be determined by your doctor.
- For generalized myasthenia gravis (gMG):
- Adults—1 single-dose prefilled syringe injected under the skin for 20 to 30 seconds once a week for 4 weeks. Each injection contains 1000 milligrams (mg) of efgartigimod alfa and 10,000 units of hyaluronidase-qvfc.
- Children—Use and dose must be determined by your doctor.
- For chronic inflammatory demyelinating polyneuropathy (CIDP):
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
If you miss a dose of this medicine, you may inject for up to 3 days after the missed dose and go back to regular dosing schedule.
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.
If needed, you may store the prefilled syringe at room temperature for up to 30 days. Do not put it back in the refrigerator. Throw away unused medicine after 30 days of room temperature storage.
Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.
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 may be needed to check for unwanted effects.
Call your doctor right away if you start to have a cough that does not go away, weight loss, night sweats, fever, chills, flu-like symptoms (eg, runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after using this medicine.
This medicine may cause hypotension (low blood pressure) which may lead to fainting. Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.
This medicine may cause infusion-related reactions. Check with your doctor right away if you have back pain, blurred vision, chest tightness, chills, dizziness, fever, flushing, headache, nausea and vomiting, nervousness, pounding in the ears, slow or fast heartbeat, stomach pain, trouble breathing, or weakness.
While you are being treated with efgartigimod alfa and hyaluronidase-qvfc combination injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with efgartigimod alfa and hyaluronidase-qvfc combination.
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 or nurse immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- cough
- difficult, burning, or painful urination
- difficulty in moving
- fever
- frequent urge to urinate
- joint pain
- lower back or side pain
- muscle aches, cramps, pain, or stiffness
- sneezing
- sore throat
- swollen joints
Incidence not known
- Back pain
- blurred vision
- chest tightness
- chills
- confusion
- difficulty breathing or swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- flushing
- headache
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nausea and vomiting
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin itching, rash, or redness
- sweating
- swelling of the face, throat, or tongue
- 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
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
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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