RYBELSUS 14/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults: as an adjunct to diet and exercise to improve glycemic control.

Off-Label Uses

Weight management/weight loss (off-label for oral semaglutide); other investigational/off-label uses include NAFLD/NASH.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: Initial 3 mg once daily for 30 days, then 7 mg once daily; if additional glycemic control needed after at least 30 days on 7 mg, increase to 14 mg once daily. Maximum dose: 14 mg once daily

Initial Dose

3 mg once daily for the first 30 days (dose initiation period only, not therapeutically effective)

Maintenance Dose

7 mg once daily; may increase to 14 mg once daily if additional glycemic control is needed

Maximum Dose

14 mg once daily.

Children's Dosage

Not approved for children under 18 years of age.

Dose Adjustment Notes

Titration is required: 3 mg once daily for 30 days (initiation; not effective for glycemic control) → 7 mg once daily for at least 30 days → may increase to 14 mg once daily if additional control needed. No dose adjustment is generally required for renal or hepatic impairment, but monitor if severe GI reactions cause dehydration/AKI risk. If used with insulin or a sulfonylurea, consider lowering the insulin/sulfonylurea dose to reduce hypoglycemia risk.

How to Take

Take Rybelsus once daily on an empty stomach upon waking. Swallow the tablet whole (do not split, crush, or chew) with no more than 120 mL (4 oz) of plain water only. Wait at least 30 minutes before eating, drinking anything other than water, or taking any other oral medications; then you may eat/drink/take other oral meds.

Side Effects

Common Side Effects

Nausea, diarrhea, vomiting, abdominal pain, constipation, decreased appetite, dyspepsia.

Side Effect Frequency

Very common (>10%): nausea, diarrhea. Common (1-10%): vomiting, constipation, abdominal pain, decreased appetite, dyspepsia, eructation, flatulence, gastroesophageal reflux disease, fatigue; hypoglycemia is mainly increased when used with insulin or a sulfonylurea. Uncommon/rare: acute pancreatitis, hypersensitivity reactions; diabetic retinopathy complications have been reported (notably in patients with pre-existing retinopathy and rapid glycemic improvement).

Safety & Warnings

Contraindications

Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), hypersensitivity to semaglutide or any excipient, history of serious hypersensitivity reaction to semaglutide

Warnings & Precautions

Boxed warning/contraindication for MTC/MEN2; pancreatitis-discontinue if suspected; hypoglycemia risk when combined with insulin/secretagogues; acute kidney injury-monitor renal function especially with severe GI symptoms/dehydration; diabetic retinopathy complications with rapid glycemic improvement; hypersensitivity reactions; gallbladder disease; not for type 1 diabetes or DKA; administration must be on an empty stomach with a small amount of water and wait before food/other oral meds to ensure absorption.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Increased hypoglycemia risk with insulin or insulin secretagogues (e.g., sulfonylureas) - consider dose reduction. Delays gastric emptying and may affect absorption of concomitant oral drugs; monitor drugs with narrow therapeutic index (e.g., warfarin) and levothyroxine as clinically indicated.

Interaction Severity

MAJOR/clinically significant: insulin and sulfonylureas (increased hypoglycemia risk-consider dose reduction and monitor). MODERATE: drugs where small exposure changes matter due to delayed gastric emptying/administration separation (e.g., levothyroxine-exposure may increase; monitor and separate as directed; warfarin-monitor INR when starting/changing therapy). Generally MINOR: most other oral drugs (possible delayed Tmax; usually not clinically meaningful).

Food Interaction

Must be taken fasting: take with ≤120 mL plain water only and wait ≥30 minutes before any food, beverage (including coffee), or other oral medications; food significantly reduces absorption.

Special Populations

Pregnancy

Risk Summary: Available data insufficient; animal data suggest risk; clinical considerations for use.

Children

Not approved for children under 18 years of age.

Kidney Impairment

No dosage adjustment recommended in renal impairment, including severe impairment; use caution and monitor renal function in patients who develop severe GI reactions/dehydration (and in ESRD due to limited experience).

Liver Impairment

No dosage adjustment recommended in hepatic impairment.

Storage & Patient Advice

Missed Dose

If a dose is missed, skip it and take the next dose the following day at the usual time; do not take two doses in the same day.

Stopping the Medicine

Can be stopped without tapering; advise not to stop without prescriber input because glycemic control may worsen, and ensure alternative diabetes therapy if needed.

Overdose

Overdose may cause severe nausea/vomiting and hypoglycemia (especially with insulin/secretagogues); management is supportive with monitoring and treatment of hypoglycemia as needed, and prompt medical evaluation is recommended.

Patient Counseling

Take first thing in the morning on an empty stomach with ≤120 mL plain water only; swallow whole; wait ≥30 minutes before any food/drink/other oral meds. Expect GI upset (nausea/diarrhea) especially during dose increases; eat smaller, lower-fat meals and stay hydrated. Seek urgent care for severe persistent abdominal pain (pancreatitis) or signs of dehydration/renal issues. Know hypoglycemia symptoms if also using insulin/sulfonylurea. Report vision changes (retinopathy risk with rapid improvement). Contraindicated/avoid in patients with personal/family history of medullary thyroid carcinoma or MEN2; report neck mass/hoarseness/dysphagia. Use in pregnancy is not recommended-discuss pregnancy plans with prescriber.

Monitoring Requirements

Monitor glycemic control (SMBG as appropriate; HbA1c about every 3 months until stable then at least every 6 months). Monitor for pancreatitis symptoms, renal function if significant GI adverse effects/dehydration occur, and diabetic retinopathy complications in patients with pre-existing retinopathy or rapid glucose improvement. Monitor for hypoglycemia when used with insulin/sulfonylurea; counsel on thyroid C-cell tumor warning symptoms.

Pharmacology

Mechanism of Action

GLP-1 receptor agonist: increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, slows gastric emptying, and reduces appetite/energy intake.

Duration of Effect

Once-daily dosing provides 24-hour coverage; semaglutide has an elimination half-life of about 1 week.

Half-Life

Approximately 1 week (168 hours)

Product Information

Available Dosage Forms

Tablet (oral semaglutide) - this product is a 14 mg oral tablet.

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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