Package leaflet · information for the user
Retatrutide Dual Chamber 30 mg
Retatrutide
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
1.What Retatrutide Dual Chamber is and what it is used for
Retatrutide Dual Chamber is a solution for injection in a dual-chamber pen. The pen has two chambers that you combine in the device before the first injection, following the instructions in the pack. Retatrutide acts on three signals the body uses to control appetite and blood sugar (GLP-1, GIP and glucagon). Your doctor has prescribed it to be injected under the skin once a week. The pen holds 30 mg and is marked to give 10 mg at each dose. It is prescription-only and must not be used by anyone else.
2.What you need to know before you use Retatrutide Dual Chamber
Read this section before you combine the chambers or give the first injection. The pen lives in the refrigerator and must never be frozen.
Do not use it if
- Do not use it if you are allergic to retatrutide or to any of the other ingredients listed on the carton.
- Do not use it if you or a close relative have had medullary thyroid cancer, or if you have a condition called multiple endocrine neoplasia type 2.
- Do not use it if you are pregnant or planning to become pregnant.
- Do not use it if you have had pancreatitis, unless your doctor has specifically told you to.
Warnings and precautions
- Talk to your doctor before using it if you have diabetes and take insulin or a sulfonylurea tablet. Your blood sugar can fall too low, and those doses may need to come down.
- Talk to your doctor before using it if you have kidney trouble, stomach trouble, or have had gallstones.
- Drink enough fluid. Nausea, vomiting or diarrhoea can dry you out, which is harder on the kidneys.
- Stop and get medical help if you get severe pain in the stomach that will not go away, with or without vomiting. It can be a sign of an inflamed pancreas.
- A lump in the neck, hoarseness, or trouble swallowing should be reported to your doctor.
Other medicines and Retatrutide Dual Chamber
Tell your doctor or pharmacist about all other medicines you take, including ones bought without a prescription. It is especially important to mention insulin and sulfonylurea tablets, because together they can make your blood sugar fall too far; warfarin or other blood thinners; thyroid tablets; and the oral contraceptive pill, because this medicine slows the stomach and can change how tablets are absorbed.
Pregnancy, breastfeeding and fertility
Do not use this pen if you are pregnant or planning to become pregnant. Stop it before a planned pregnancy and tell your doctor, because the medicine stays in the body for days after the last dose. Do not use it while breastfeeding. Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
This medicine is not expected to affect driving by itself. If you take it with insulin or a sulfonylurea and your blood sugar falls, do not drive until it is normal again.
3.How to use Retatrutide Dual Chamber
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Before the first injection, combine the two chambers the way the pack shows you. Do not inject until that step is finished and the solution looks as the instructions describe. Then inject under the skin of the abdomen, thigh or upper arm, once a week, on the same day each week. The carton is marked 10 mg per dose. Attach a new needle each time, use a different spot each week, and take the needle off afterwards. Do not inject into a vein or a muscle. Do not share the pen. If you miss a dose, ask your doctor what to do. Do not inject two doses to make up for a missed one.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop and get medical help straight away
- A severe allergic reaction: swelling of the face, lips, tongue or throat, or trouble breathing. Get emergency help at once.
- Severe stomach pain that does not go away, with or without vomiting. This can be pancreatitis. Get medical help now.
- Signs of very low blood sugar: sweating, shaking, confusion, or feeling faint. Take sugar and contact your doctor.
- Pain under the right ribs, fever, or yellowing of the skin or eyes. These can be a gallbladder problem.
- A lump in the neck, persistent hoarseness, or trouble swallowing. Contact your doctor.
Other possible side effects
- Feeling sick, or being sick
- Diarrhoea or constipation
- Stomach pain or indigestion
- Less appetite
- Redness or itching where you injected
- Feeling tired
- A faster heartbeat
- Low blood sugar if you also take insulin or a sulfonylurea
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist — including any not listed in this leaflet. You can also report them directly to us at pv@ergopharm.net or through our reporting form, and to your national reporting system. By reporting side effects you help provide more information on the safety of this medicine.
5.How to store Retatrutide Dual Chamber
Keep this medicine out of the sight and reach of children. Store the unused pen in a refrigerator at 2–8 °C. Do not freeze it. Keep it in the carton to protect it from light. After the chambers have been combined, put the pen back in the refrigerator with the cap on, and never leave a needle on it. Do not use it after the expiry date on the carton. Do not use the pen if the liquid looks wrong compared with the instructions. Needles and the used pen must go back to a pharmacy or into a sharps bin, not into household rubbish.
6.Contents of the pack and other information
The active substance is retatrutide. The dual-chamber pen contains 30 mg of retatrutide and is marked to give 10 mg once weekly after the chambers are combined. The carton contains 1 dual-chamber pen and 10 disposable needles. The other ingredients are printed on the carton. The carton is marked Rx only, serialised, and for export only. Manufactured under GMP conditions by Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India.