Post administration of octreotide LAR , drug release is controlled by the slow biodegradation of its microsphere polymer matrix. Once released into circulation, octreotide follows known pharmacokinetics.

After a single intramuscular (IM) injection in healthy volunteers, octreotide serum concentrations show an initial peak (~0.03 ng/mL/mg) within 1 hour, followed by a decline over 3–5 days to <0.01 ng/mL/mg. A gradual increase leads to plateau levels after 2–3 weeks, which persist for another 2–3 weeks before declining from Week G, reaching <0.01 ng/mL/mg by Weeks 12–13. The relative bioavailability compared to the immediate-release subcutaneous (SC) injection is G0%–G3%.

In carcinoid tumor patients, mean octreotide concentrations after G doses of 10 mg, 20 mg, and 30 mg were 1.2 ng/mL, 2.5 ng/mL, and 4.2 ng/mL, respectively. Steady-state levels were reached after 2 injections of 20 mg and 30 mg and 3 injections of 10 mg.

Ostreosad LAR depot has not been studied in patients with renal or hepatic impairment.

 Drug interactions

• Octreotide injections may be taken with or without food.
• Using alcohol or tobacco with certain medicines may interfere with drug efficacy.
• Inform healthcare providers about all food, alcohol, tobacco, medications and supplements taken during octreotide therapy.
• Due to its association with alterations in nutrient absorption, octreotide may affect the absorption of orally administered drugs.
• Drugs like cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, calcium channel blockers, agents to control fluid and electrolyte balance and bromocriptine are known to have interactions with In such cases, a dose adjustment may be required with consultation of the doctor.
• Concomitant administration of octreotide injection with cyclosporine can lead to decrease in blood levels of cyclosphorine.
• Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine.
• According to some published data, somatostatin analogs can decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, most possibly due to the suppression of growth hormones.

• Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.
• Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered  drugs.
• Concomitant administration of Sandostatin with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.
• Discontinue octreotide LAR therapy at least 4 weeks prior to each lutetium Lu 177 dotatate dose.
• No known interference exists with clinical laboratory tests, including amine or peptide determination.

 Important:

        Prior to initiating treatment, it is essential to engage in a comprehensive discussion with your healthcare provider regarding any current medications, medical conditions, pregnancy status, or intentions for breastfeeding. This dialogue allows your doctor to evaluate potential drug interactions and customize a treatment regimen that aligns with your specific requirements, emphasizing your safety and health. For personalized information and guidance, it is recommended to seek further clarification and advice from your doctor.

The medicine is to be administered by a healthcare professional in a proper hospital setting, in the form of an injection (strictly intramuscular administration). The dose, route of administration, and frequency will be decided by the physician based on your diagnosis.

Use in Specific Population

 Based on the patient’s diagnosis and prognosis, the physician may take the following into consideration before adjusting use and dosage:

Pregnancy

• Insufficient data to establish a drug associated risk in pregnant women in implications like birth defects, malformations or miscarriage
• Animal reproduction studies were done to establish a maximum recommended human dose (MRHD) of 5 mg/day based on body surface area (BSA).

• However, it is important to note that animal studies showed transient growth retardation with no impact on postnatal development in rats at IV doses below the MRHD based on BSA.
• Hence, it is important to consult a physician and see if the risk outweighs the benefit from the drug
• In the S. general population, estimated background risk of major birth defects and miscarriage in pregnancies is 2-4% and 15-20% respectively.

Allergies

• Inform doctor for any existing medicine, food, dye, preservative, or animal allergy as well as any allergy that developed after the use of the drug.

Pediatric

• Appropriate studies or controlled trials to demonstrate any correlation between age of patient and the safety and efficacy of the drug usage in the pediatric population (< G years)has not been performed.
• However, it is important to note that some post marketing reports reported severe reactions including hypoxia, necrotising enterocolitis and even death in children, mostly 2 years and below, undergoing treatment with octreotide.
• Given the pre-existing comorbidity, a proper connection between octreotide usage and the serious adverse reactions cannot be established.

Geriatric

• There is a lack of sufficient clinical studies of octreotide’s effect on people aged G5 years and above and any significant difference on the effect on young versus
• Despite the lack of sufficient studies relating age related issues to octreotide associated adverse reactions, geriatric specific problems are not expected to limit the efficacy of this drug, when administered to the elderly.
• However, keeping in mind the age-related complications like renal, hepatic, or cardiac problems, which may require caution, the doctor may adjust the dose for patients undergoing octreotide treatment.

Breastfeeding

• There has been evidence of octreotide passing into milk of lactating rats, when administered However, since there is a difference in the lactation physiology of humans with rats, this information is not very reliable.
• There is no relevant information available on the presence of octreotide in human milk, its effects on the breastfed infant, or the effects of the drug on milk production.
• Also, consider the underlying conditions of the breastfeeding mother.

• Weigh the potential benefits against the potential risks before taking this medication while breastfeeding and exercise caution should be exercised when octreotide is administered to a nursing

Reproductive potential

• Given the poor understanding of the effect of the drug on babies and nursing mothers, it is important to discuss potential pregnancies in premenopausal women.
• Due to the effects of the drug in acromegalic females, like reduction of growth hormone and normalisation of insulin-like growth factor 1 (IGF-1) concentration may lead to improved fertility.

 Renal or hepatic impairment

• The dosage in patients with renal or hepatic failure needs to be regulated and monitored strictly by the Dosage may be adjusted based on the patient’s clinical response and tolerability.
• For patients with established liver cirrhosis or renal failure and undergoing dialysis, may be started with a dose of 10mg.
• This dose should then be increased based on the patient’s response and speed of that response, as seen fit by physician.
• Patients with mild, moderate, or severe renal impairment more often don’t need an adjustment in the starting dose.

Contraindications

None..