100 mg Concentrate for infusion solution
eptinezumab
What VYEPTI is and what it is used for
VYEPTI contains the active substance eptinezumab, which prevents the activity of calcitonin gene-related peptide er (CGRP), a substance that occurs naturally in the body. People with migraines may have elevated levels of this substance.
VYEPTI is used to prevent migraines in adults who have at least 4 migraine days per month.
VYEPTI can reduce the number of migraine days and improve your quality of life. You can feel the preventive effect starting the day after you receive this medicine.
What you need to know before you receive VYEPTI
Do not use VYEPTI
- if you are allergic to eptinezumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before receiving VYEPTI if you have a disease that affects the heart and blood vessels.
VYEPTI can cause serious allergic reactions. Such reactions can develop quickly, and can then also occur while the medicine is being given. Tell your doctor right away if you get any symptoms of an allergic reaction, such as:
- breathing difficulties
- fast or weak pulse or a sudden drop in blood pressure that makes you feel dizzy or light-headed
- swelling of the lips or tongue
- severe skin itching or rash while receiving VYEPTI, or afterward
Children and young people
VYEPTI is not recommended for children and adolescents under 18 years of age because it has not been studied in these age groups.
Other medicines and VYEPTI
Tell your doctor if you are using, have recently used, or might be using other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine.
Use of VYEPTI should preferably be avoided during pregnancy as the effects of this drug in pregnant women are unknown.
It is unknown if VYEPTI passes into breast milk. Doctors will help you decide if you should stop breastfeeding or if treatment with VYEPTI should be stopped. If you are breastfeeding or plan to breastfeed, talk to your doctor before receiving treatment with VYEPTI. You and the doctor should decide together whether you should breastfeed while receiving therapy with VYEPTI.
Driving ability and use of machinery
VYEPTI has no or negligible effect on the ability to drive and use machines.
VYEPTI contains sorbitol
Sorbitol is a source of fructose. If you have hereditary fructose intolerance, a rare, hereditary disease, you should not receive this medicine. Fructose cannot be broken down in patients with hereditary fructose intolerance, which can cause serious side effects.
If you have hereditary fructose intolerance, you must tell your doctor before receiving this medicine.
How to use VYEPTI
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
VYEPTI is given as a drip ( infusion ) into a vein. Infusion one takes about 30 minutes. You will be given VYEPTI by healthcare professionals who prepare an infusion before they give it to you. During and after the infusion, the healthcare professional will, according to standard clinical practice, monitor you for signs of an allergic reaction.
The recommended dose is 100 mg given every 12 weeks. Some patients may benefit from a dose of 300 mg given every 12 weeks. The doctor will decide the right dose for you and how long you should continue the treatment.
If you use too much VYEPTI
As you will be given the medicine by your healthcare professional, it is unlikely that you will be given too much VYEPTI. Tell your doctor if you think this has happened.
If you forget to use VYEPTI
If you forget to take a dose, the doctor will decide when the next dose should be given.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or nurse immediately if you notice any of the following side effects, you may need emergency medical treatment:
Common: may affect up to 1 in 10 users:
- allergic reaction and other side effects as a result of infusion reactions can develop rapidly during infusion one. Symptoms of an allergic reaction:
- breathing difficulties
- fast or weak pulse
- a sudden drop in blood pressure that makes you feel dizzy or light-headed
- swelling of the lips or tongue
- severe itching of the skin, rash serious allergic reactions are less common (may affect up to 1 in 100 users).
Other symptoms that may occur due to the infusion include respiratory symptoms (for example, stuffy or runny nose, throat irritation, coughing, sneezing, and shortness of breath) and feeling tired. These symptoms are usually mild and pass quickly.
Other side effects can occur with the following frequency:
Common: may affect up to 1 in 10 users:
- nasal congestion
- sore throat
- pronounced fatigue
How to store VYEPTI
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after “Expiry date”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze or shake.
Store in the outer carton. Light sensitive.
After dilution, the solution can be stored at room temperature (below 25 °C) or in a refrigerator at 2 °C – 8 °C. The diluted infusion solution must be given within 8 hours.
Do not use this medicine if you notice that the solution contains visible particles or is cloudy or discolored.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is eptinezumab. Each vial of concentrate contains 100 mg eptinezumab per ml.
- Other ingredients are sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and water for injection.
Appearance and package sizes of the medicine
VYEPTI concentrate for infusion is clear to slightly milky, and colorless to brownish yellow. Each vial contains one ml of concentrate in a clear glass vial with a rubber stopper, aluminum seal, and snap-on cap.
Each pack contains one single-use vial.
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark