0.25 mg powder and solvent for injection, solution
cetrorelix
1. What Cetrotide is and what it is used for
What Cetrotide is
Cetrotide contains a medicine called cetrorelix. This medicine prevents the body from secreting an egg from the ovaries (ovulation) during the menstrual cycle. Cetrotide belongs to a group of medicines called anti-gonadotropin-releasing hormones.
What Cetrotide is used for
Cetrotide is one of the drugs used in assisted reproduction techniques to help you get pregnant. This prevents the eggs from being released immediately. This is because if the eggs are released prematurely (premature ovulation), the doctor may not be able to remove them.
How Cetrotide works
Cetrotide blocks a natural hormone in the body called LHRH ( luteinizing hormone-releasing hormone ).
- LHRH controls another hormone called LH ( luteinizing hormone ).
- LH stimulates ovulation during the menstrual cycle.
This means that Cetrotide stops the chain of events that leads to an egg being released from your ovaries. When your eggs are ready to be taken out, you will receive another medicine that loosens the eggs (ovulation induction).
2. What you need to know before you use Cetrotide
Do not use Cetrotide
- if you are allergic to cetrorelix or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines similar to Cetrotide (any other peptide hormone)
- if you are pregnant or breastfeeding
- if you have severe kidney disease.
Do not use Cetrotide if any of the above apply to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and cautions
Allergy is
Tell your doctor before using Cetrotide if you have an ongoing allergic reaction or have previously had allergic reactions.
Ovarian hyperstimulation syndrome (OHSS)
Cetrotide is used with other medicines that stimulate the ovaries to develop more eggs that can be released. While or after receiving these medicines, you may develop OHSS. This happens when the follicles develop too much and become large cysts. Possible signs of this that you should pay attention to and what to do if this happens to see section 4 ” Possible side effects are .”
Use of Cetrotide for more than one cycle
Experience with the use of Cetrotide for more than one cycle is limited. Your doctor will carefully review the benefits and risks for you if you need to take Cetrotide for more than one cycle.
Liver disease
Tell your doctor before using Cetrotide if you have liver disease. Cetrotide has not been studied in patients with liver disease.
Kidney disease
Tell your doctor before using Cetrotide if you have kidney disease. Cetrotide has not been studied in patients with kidney disease.
Children and young people
Cetrotide is not intended for use by children or adolescents.
Other medicines and Cetrotide
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use Cetrotide if you are pregnant, think you may be pregnant, or are breast-feeding.
Driving and using machines
Cetrotide is not expected to affect your ability to drive and use machines.
3. How to use Cetrotide
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
How to use this medicine
This medicine is for injection only under the skin of the abdomen ( subcutaneously ). Choose different parts of the stomach every day to reduce skin irritation.
- Your doctor must monitor your first injection. Your doctor or nurse will show you how to prepare and inject the medicine.
- You can take the following injections yourself if your doctor has informed you about the symptoms that may indicate an allergic reaction and about its possible serious or life-threatening consequences that require immediate treatment (see section 4 “Possible side effects” ).
- Read carefully and follow the instructions “How to mix and inject Cetrotide” at the end of this information.
- You start by using another medicine on day 1 of your treatment cycle. You will then start using Cetrotide a few days later. (See the next section “How much to use” .)
How much to use
Inject the contents of 1 vial (0.25 mg Cetrotide) once a day. It is best to use the medicine at the same time each day with 24 hours between each dose.
You can choose to inject every morning or every evening.
- If you inject every morning: Start your injections on day 5 or day 6 of the treatment cycle. Based on how your ovaries react, your doctor may decide to start another day. Your doctor will inform you of the exact date and time. You should use this medicine until the morning your eggs are taken (ovulation induction).
OR
- If you inject every night: Start your injections on day 5 of the treatment cycle. Based on how your ovaries react, your doctor may decide to start another day. Your doctor will inform you of the exact date and time. You should use this medicine until the evening before your eggs are taken out (ovulation induction).
If you use more Cetrotide than you should
Adverse effects are not expected if you accidentally inject too much of this medicine. The effect of the drug will be longer. Usually, no special measures are required.
If you forget to use Cetrotide
- If you forget to take a dose, inject it as soon as you remember and contact your doctor.
- Do not inject a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
- Feeling of heat and redness of the skin, itching (often in the groin or armpits), redness, itching, raised rash (hives), runny nose, rapid or uneven pulse, swelling of the tongue and throat, sneezing, wheezing, or severe difficulty breathing, or dizziness. You may have had a severe, life-threatening allergic reaction to the medicine. This is less common (affects up to 1 in 100 women).
If you experience any of the side effects mentioned above, stop using Cetrotide and contact your doctor immediately.
Ovarian hyperstimulation syndrome (OHSS)
This may be due to the other medicines you use to stimulate the ovaries.
- Abdominal pain along with nausea or vomiting may be symptoms of OHSS. This may indicate that the ovaries have overreacted to the treatment and that large ovarian cysts have formed. This is common (may affect up to 1 in 10 women).
- OHSS can become serious with clearly enlarged ovaries, decreased urine flow, weight gain, difficulty breathing, or fluid in the abdomen or chest cavity. This is less common (affects up to 1 in 100 women).
If you get any of the side effects listed above, contact your doctor immediately.
Other side effects are
Common (may affect up to 1 in 10 women):
- Mild and short-term skin irritation may occur at the injection site, e.g. redness, itching, or swelling.
Uncommon (may affect up to 1 in 100 women):
- Feeling sick (nausea)
- Headache.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cetrotide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label on the carton, vial, and prefilled syringe after “EXP” and “EXP”, respectively. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze or place next to the freezer compartment or a cooling lamp.
Store in the original package. Sensitive to light.
Unopened medicine can be stored in the original package at room temperature (at a maximum of 30 ° C) for up to 3 months.
The solution for injection should be used immediately after reconstitution.
Do not use this medicine if you notice that the white powder in the bottle has changed its appearance. Do not use the reconstituted liquid in the vial if it is no longer clear and colorless or if it contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is cetrorelix. Each vial contains 0.25 mg cetrorelix (as acetate).
- Other ingredients are:- In powder: mannitol- In the liquid: water for injections
What the medicine looks like and the contents of the pack
Cetrotide is a powder and solvent for solution for injection. The white powder is supplied in a glass vial with a rubber stopper. The liquid is a clear and colorless solution in a pre-filled syringe.
The powder vial contains 0.25 mg of cetrorelix and the pre-filled syringe contains 1 ml of liquid.
The medicine is available in packs of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes (not all pack sizes may be marketed).
The pack for each vial also contains:
- a yellow-marked needle – to inject the sterile water into the vial and to pull the reconstituted medicine out of the vial
- a gray-marked needle – to inject the drug into the stomach
- two compresses moistened with alcohol for cleaning
Marketing Authorisation Holder
Merck Europe BV, Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Manufacturer
Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu