GLP-1 Tirzepatide & B6 10mg (10mg/1mL)

Route: Subcutaneous injection. Administer into the abdomen, thigh, or upper arm. Rotate injection sites with each dose to minimize local reactions. Do not inject into areas of active skin irritation, redness, or scarring. Inject once weekly on the same day each week; day may be changed if at least 3 days separate doses.

Dosing is prescriber-determined and individualized to patient response and tolerability. General titration principles based on the pharmacology of tirzepatide:

• Initiation typically begins at a low dose (e.g., 2.5 mg weekly) with gradual escalation at 4-week intervals.
• This 10 mg vial (10 mg/mL) delivers a single 1 mL dose at the 10 mg maintenance level.
• Dose escalation should be slowed or paused if gastrointestinal side effects are intolerable.
• Final dosing schedule and increments are determined by the prescribing clinician.

• Tirzepatide: Acts as a dual agonist at both glucose-dependent insulinotropic polypeptide (GIP) receptors and glucagon-like peptide-1 (GLP-1) receptors. GIP receptor agonism potentiates insulin secretion and may enhance fat metabolism; GLP-1 receptor agonism augments glucose-dependent insulin release, suppresses glucagon, delays gastric emptying, and activates hypothalamic satiety centers to reduce caloric intake.
• Pyridoxine (B6): Serves as a cofactor in the biosynthesis of serotonin, dopamine, and GABA — neurotransmitters that modulate the central and peripheral nausea pathways activated by GLP-1 receptor agonism. Supportive inclusion aimed at improving GI tolerability.

Tirzepatide is clinically employed in the management of type 2 diabetes mellitus and, under prescriber direction, obesity (overweight with comorbidities). The compounded tirzepatide + B6 formulation is prepared for patient-specific use where commercially available products are not accessible or where the prescriber has determined this specific preparation is appropriate.

Monitoring considerations:

• Fasting glucose, HbA1c at baseline and periodically during therapy.
• Renal function (BUN/creatinine) if significant GI fluid losses occur.
• Thyroid surveillance: GLP-1 receptor agonists carry a class warning for medullary thyroid carcinoma; obtain personal and family history of MTC or MEN2.
• Monitor for pancreatitis: unexplained persistent abdominal pain should prompt discontinuation and evaluation.
• Injection site inspection at each visit.

Contraindications:

• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Known hypersensitivity to tirzepatide or any formulation excipient.

Warnings & Precautions:

• Risk of thyroid C-cell tumors (class effect); not for use in patients with MTC/MEN2 history.
• Pancreatitis: discontinue if suspected.
• Hypoglycemia risk, especially in patients on concomitant insulin or sulfonylureas.
• Acute kidney injury risk secondary to dehydration from GI side effects.
• Gastroparesis/bowel obstruction: use with caution in patients with known GI motility disorders.
• Pyridoxine toxicity is rare at physiologic supplemental doses, but prolonged excessive B6 (>100 mg/day) may cause peripheral neuropathy.

Drug Interactions:

• Tirzepatide delays gastric emptying and may affect absorption of orally administered drugs; oral medications with narrow therapeutic indices require monitoring.
• Additive hypoglycemia risk with insulin secretagogues and insulin.

Common Side Effects: Nausea, vomiting, diarrhea, constipation, decreased appetite, abdominal discomfort, injection site reactions. GI effects most common during initiation and dose escalation.

Store compounded tirzepatide injectable solution refrigerated at 2°C–8°C (36°F–46°F). Protect from light; store in original container. Do not freeze. Once removed from refrigeration, may be kept at room temperature (up to 30°C) for limited periods per the beyond-use date assigned by Genesis Compounding. Do not use after the beyond-use date printed on the label. Discard unused product properly.

How is this injection administered?

Tirzepatide & B6 is given as a once-weekly subcutaneous injection into the abdomen, thigh, or upper arm. Rotate the injection site each week and avoid areas of skin irritation or scarring. Your prescriber or pharmacist can demonstrate proper injection technique.

Why is vitamin B6 included in this formulation?

Pyridoxine (B6) is included as a supportive adjunct. GLP-1 receptor agonists commonly cause nausea, particularly during dose escalation. B6 participates in neurotransmitter synthesis (serotonin, GABA) and has antiemetic properties used clinically in other nausea settings, providing potential tolerability support during tirzepatide therapy.

Is this the same as Mounjaro® or Zepbound®?

No. This is a compounded preparation of tirzepatide prepared by Genesis Compounding as a patient-specific, prescriber-directed 503A product. It is not FDA-approved as a compounded drug and is distinct from commercially manufactured branded products.

What should I do if I experience severe nausea or abdominal pain?

Mild nausea is common and often resolves with dose titration. Severe or persistent vomiting, inability to keep fluids down, or significant abdominal pain (especially radiating to the back) should be reported to the prescriber immediately, as these may indicate pancreatitis or other serious complications.

How should I store this medication?

Keep refrigerated at 2°C–8°C. Do not freeze. Protect from light and use before the beyond-use date on the label.