Sandosphere LAR® 30 mg

Description

Sandosphere LAR® is a long-acting release somatostatin analogue. Sandosphere LAR® is supplied in a sterile lyophilized form as a white to white-off powder in vials containing 20 mg or 30 mg of octreotide acetate and accompanied by solvent ampule containing 2.5 ml of mannitol and sodium-carboxymethyl cellulose, syringe and two needles (Long for preparation and short for the main injection).

Sandosphere LAR® API is manufactured in Bachem Co. Switzerland and Corbion Co. Netherlands, microsphere and QC tests were developed and done by Primm Co., Italy, and Homa Pharmed Co. produces the final product.

Labeled Indications

• Long-term treatment of severe diarrhea and flushing episodes associated with carcinoid syndrome in patients with metastatic GEP-NETs
• Long-term treatment of profuse watery diarrhea associated with VIPomas
• Treatment of patients with Advanced NETs with unknown primary tumor location ‌
• First-line therapy for Acromegaly patients with persistent disease despite surgical resection or in whom surgery and/or Radiotherapy is inappropriate or ineffective

Contraindication

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 follow the mixing instructions including in the packaging, closely.

Sandosphere LAR® must be administered immediately after mixing.

Sandosphere LAR® 20mg and 30mg should be administrated intramuscularly in the gluteal region at 4-week intervals (28 Days) and administration intervals should not be more than 4 weeks.

Injection sites should be rotated systematically to avoid irritation.

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

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

Do not warm it artificially.

Side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Diarrhea, Fatigue, Nausea, Vomiting, Headache, Abdominal pain, Constipation, Flatulence, Thyroid dysfunction, Gall bladder abnormalities, Hyperbilirubinemia, Impaired glucose tolerance, Blood glucose disturbances, Vit B deficiency

Special Warning and Precautions

GH reduction and IGF1 balancing may cause restoring fertility power. So, Women of reproductive age are advised to use appropriate contraceptives during treatment with Octreotide if they do not intend to get pregnant.

For more information about warnings please contact healthcare professionals.

Pregnancy and lactation:

Octreotide crosses the placenta and can be detected in the newborn at delivery and Data concerning use in pregnancy are limited. Therefore, the decision depends on your doctor.

Octreotide is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother by your doctor.

Storage

Sandosphere LAR® should be stored at the refrigerated temperature of 2-8 ˚C and protected from light.

Sandosphere LAR® should be allowed to come to room temperature 30 minutes before preparing.

Do not warm artificially.

Keep away from children.