Retatrutide Single Chamber 30 mg

Retatrutide Single Chamber 30 mg (Retatrutide)

Triple agonist · GLP-1, GIP and glucagon receptors

Each single-chamber adjustable-dose pen contains retatrutide 30 mg as a solution for injection, labelled to deliver 10 mg per dose, once weekly. The carton contains 1 pen and 10 disposable needles.

For the full list of excipients, see section 6.1.

Solution for injection in a prefilled pen for once-weekly subcutaneous use.

Therapeutic indications

Metabolic therapy where a once-weekly GLP-1, GIP and glucagon receptor agonist is prescribed, as determined by a physician.

Posology and method of administration

Inject subcutaneously once weekly, as directed by a physician. This pen is labelled to deliver 10 mg per dose. Attach a new needle for each injection, rotate sites, and do not inject into a vein or a muscle.

Contraindications

Known hypersensitivity to retatrutide or to any excipient. Personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia syndrome type 2. Pregnancy. A history of pancreatitis is a reason to avoid use unless a physician has specifically decided otherwise.

Special warnings and precautions for use

Keep out of the reach and sight of children.

Interaction with other medicinal products

Insulin and sulfonylureas

Additive glucose-lowering. The dose of insulin or the sulfonylurea often needs to be reduced when retatrutide is started, and glucose should be monitored.

Oral medicines with a narrow therapeutic index

Delayed gastric emptying can change the absorption of oral medicines, including levothyroxine, digoxin and oral contraceptives. Take them as the prescriber directs and watch the clinical effect.

Warfarin and other coumarins

Absorption and nutritional status can shift the anticoagulant effect. Check the INR more often after starting or stopping retatrutide.

Use in special populations

Pregnancy and breastfeeding

Do not use in pregnancy. Weight-loss medicines are not used in pregnancy, and there are no adequate data for retatrutide. Stop the pen before a planned pregnancy, allowing for its multi-day half-life. Use while breastfeeding is not recommended.

Paediatric population

Not indicated. Safety and efficacy in children have not been established for this presentation.

Elderly

No dose change is implied by age alone. Older patients are more vulnerable to dehydration from nausea and vomiting, and to hypoglycaemia if they also take insulin or a sulfonylurea.

Renal impairment

The peptide is not cleared by the kidney as the parent drug, but gastrointestinal fluid loss can worsen renal function. Maintain hydration, and use additional caution in severe impairment.

Hepatic impairment

Use with caution in severe hepatic impairment. There is no established dose adjustment for mild or moderate impairment.

Thyroid and pancreatic disease

Do not use in people with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2. Stop and investigate if pancreatitis is suspected — severe, persistent abdominal pain, often radiating to the back.

Undesirable effects

Gastrointestinal

Nausea, vomiting, diarrhoea, constipation, abdominal pain, dyspepsia and reduced appetite — usually most noticeable while the dose is being established

Metabolism

Hypoglycaemia when combined with insulin or a sulfonylurea; dehydration secondary to gastrointestinal loss

Hepatobiliary

Gallbladder events, including cholelithiasis and cholecystitis, have been reported with this class

General and administration site

Injection-site redness, itching or a lump; fatigue; increased heart rate

Investigations

Raised pancreatic enzymes; heart-rate increase

Immune system

Hypersensitivity, including rash and, rarely, anaphylaxis or angioedema

Overdose

An overdose extends the gastrointestinal effects — prolonged nausea, vomiting and diarrhoea — and can cause dehydration and, with insulin or a sulfonylurea, hypoglycaemia. There is no specific antidote. Stop further doses, replace fluid, monitor glucose, and treat supportively. Because the half-life is several days, symptoms can last more than a week.

Pharmacodynamic properties

Retatrutide is a single peptide that agonises three receptors: glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon. GLP-1 and GIP receptor agonism increase glucose-dependent insulin secretion, slow gastric emptying and reduce appetite; glucagon receptor agonism adds energy expenditure and hepatic lipid effects. Together they lower body weight and improve glycaemic measures in people for whom a physician prescribes the medicine. This presentation is a single-chamber adjustable-dose pen: the solution is ready to inject, and the carton labels each dose as 10 mg given once weekly.

Pharmacokinetic properties

After subcutaneous injection retatrutide is absorbed slowly. Exposure supports once-weekly dosing, with an apparent half-life of the order of six days, so steady state is approached over several weeks of weekly injections. It is a peptide and is cleared by proteolysis rather than by cytochrome P450. The pen contains 30 mg and is labelled to deliver 10 mg at each weekly dose.

List of excipients

Solution for injection in a single-chamber adjustable-dose pen. Excipients are those stated on the pen label and carton. No antimicrobial preservative should be assumed beyond what the label declares.

Incompatibilities

Do not mix the pen contents with any other medicinal product. Do not attempt to refill or transfer the solution.

Shelf life

36 months from the date of manufacture when stored refrigerated at 2–8 °C in the unopened carton.

After first opening

After the first injection, keep the pen at 2–8 °C with the cap on, do not freeze it, and do not store it with a needle attached. Discard the pen after the last labelled dose, or at the end of the in-use period in the approved leaflet, whichever comes first.

Storage

Store refrigerated at 2–8 °C. Do not freeze. Keep the pen in the outer carton to protect it from light. Do not store with a needle attached.

Container

One single-chamber adjustable-dose pen containing retatrutide 30 mg, labelled 10 mg per dose once weekly, plus 10 disposable needles, in a tamper-evident, GS1-serialised outer carton with the patient leaflet. Code on the carton: ERD/INJ-28. Not all pack sizes may be marketed.

Disposal

Used needles are sharps and must not go into household waste. The used pen and unused needles should be disposed of in accordance with local requirements.

Pack

1 adjustable-dose pen · 10 needles

GTIN

05012345678929

Serial

2910 4667 8901 29

LOT

RT2901A

MFG

09 / 2028

EXP

09 / 2031

Every carton carries a GS1 DataMatrix and a verification code; a pack can be checked at ergopharm.net/verify.

Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For Export Only.

Report a suspected adverse reaction or quality defect to pv@ergopharm.net.