Sandosphere LAR® 30 mg

Description

Sandosphere LAR® is a long-acting release (LAR) formulation of octreotide, a somatostatin analogue. It is supplied as a sterile lyophilized powder (white to off-white) in vials containing 20 mg or 30 mg of octreotide (as acetate). The kit includes a separate ampule with 2.5 mL of solvent (containing mannitol and sodium carboxymethylcellulose), a syringe, and two needles (long needle for r and short needle for injection).

The active pharmaceutical ingredient (API) is manufactured by Bachem Co. (Switzerland) and Corbion Co. (Netherlands). Microsphere development and quality control testing are performed by Primm Co. (Italy). The final product is assembled and produced by Homa Pharmed Co.

Indications

– Acromegaly: For use in patients with persistent disease following surgery or in whom surgery is not appropriate

– Long-term treatment of severe diarrhea and flushing episodes associated with carcinoid syndrome

– Long-term treatment of profuse watery diarrhea associated with VIPomas

Contraindications

– Hypersensitivity to octreotide acetate or any component of the formulation

Administration

Sandosphere LAR® should be administered by a trained healthcare provider. It is essential to closely follow the mixing instructions included in the packaging.

Sandosphere LAR® must be administered immediately after mixing.

Sandosphere LAR® 20 mg and 30 mg should be administered by deep intramuscular injection in the gluteal region at 4-week intervals. Do not exceed 4-week intervals between injections.

Injection sites should be alternated (left and right gluteal) to avoid irritation.

Deltoid injection should be avoided due to significant discomfort at the injection site.

Use the long needle for reconstituting the suspension and the short needle for injection.

Allow the vial to reach room temperature naturally; do not warm it artificially.

Side Effects

All medications can cause side effects. Many patients experience no side effects or only minor ones. Contact your doctor if any of these side effects bother you, persist, or if you experience any other effects:

– Diarrhea

– Fatigue

– Nausea

– Vomiting

– Headache

– Abdominal pain

– Constipation

– Flatulence

– Thyroid dysfunction

– Gallbladder abnormalities (including gallstones)

– Impaired glucose tolerance or blood glucose disturbances

– Vitamin B12 deficiency

Special Warnings and Precautions

Suppression of growth hormone (GH) and normalization of IGF-1 levels may restore fertility. Women of childbearing potential should use effective contraception during treatment with octreotide if pregnancy is not desired.

Therapy with the octreotide LAR injection solution formulation should be withheld at least 2 months prior to administration of radiolabeled somatostatin analogs.

For additional warnings and precautions, consult a healthcare professional.

Pregnancy and Lactation

Limited data are available on the use of octreotide in pregnant women. Octreotide crosses the placental barrier and may be detected in the newborn. Sandosphere LAR® should only be used during pregnancy if clearly needed and after careful assessment of the risks and benefits by a physician.

Octreotide is excreted in breast milk. The decision whether to discontinue breastfeeding or to discontinue/abstain from therapy should take into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. This decision should be made in consultation with a physician.

Storage

– Store Sandosphere LAR® refrigerated at 2–8°C and protect from light.

– Allow the kit to reach room temperature naturally for at least 30 minutes prior to reconstitution.

– Do not warm artificially.

– Keep out of the reach of children.