LANREOTIDE INJECTION
Lanreotide Injection is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival
| DETAILS |
|---|
| NDC | 69097-870-67 |
| STRENGTH | 120 mg*/0.5 mL |
| SELLING UNITS PER SHIPPING CASE | 30 |
| MINIMUM ORDER QUANTITY | 1 |
*Each syringe contains Lanreotide 120 mg (provided as Lanreotide acetate)
Packaging Information
The box includes the following items:
- Sterile needle pack containing Sterile needle
- Sterile Laminated pouch with sterile syringe pre-filled with LANREOTIDE INJECTION
- Instructions for Use Leaflet
- Prescribing Information Leaflet
Lanreotide must be refrigerated, do not allow it to reach room temperature until ready to use. Do not place in freezer.
Lanreotide Syringe Design
Instructions for Use
- Read all instructions carefully before starting the injection. Follow this procedure exactly, as it may differ from your past experience.
- This is a single-use pre-filled syringe with a single-use safety needle with a green needle shield (that cannot be removed) in a clear needle cap.
- ALL the medication must be injected SLOWLY over 20 seconds during the use.
- If you drop or damage the device in any way, please call 1-866-604-3268.
CAUTION
- NEVER TOUCH OR TRY TO OPEN THE GREEN NEEDLE SHIELD throughout the course of operation of the device.
- Green needle shield is NOT a removable cap or cover for the needle.
- Green needle shield will automatically activate once the injection is complete.
- Green needle shield is a self-operating safety lock mechanism.
- Needle is fully covered by green needle shield.
- Needle is visible only through a small window in the green needle shield.
- Inject medication slowly over 20 seconds.
- DO NOT rush the injection.
- Remove box from refrigerator 30 minutes prior to injecting.
- Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 24 hours may be returned to the refrigerator for continued storage and usage at a later time.
- Stretch out the skin around injection site to make it flat and tight using your thumb and index finger.
- DO NOT pinch the skin around injection site.
Do NOT remove and Do NOT touch the green needle shield.
The Green Needle Shield is a protective device to prevent needle stick injuries. After completion of the injection, the green needle shield will retract automatically and lock. NEVER touch the green needle shield. Remove the clear needle cap immediately before injection. Click below to view instructions for use. Read all instructions carefully before starting the injection.
Instructional Use Video
To inquire about ordering directly from Cipla, please fill out the form below
WANT TO LEARN MORE ABOUT
LANREOTIDE INJECTION
120 mg*/0.5 mL
*Each syringe contains 120 mg (provided as Lanreotide acetate)
WANT TO LEARN MORE ABOUT
LANREOTIDE INJECTION
120 mg*/0.5 mL
*Each syringe contains 120 mg (provided as Lanreotide acetate)
Indications
Lanreotide Injection is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
Important Safety Information
Contraindications: Hypersensitivity to lanreotide.
Warnings and Precautions
Cholelithiasis and Complications of Cholelithiasis: Monitor patients periodically. Discontinue if complications of Cholelithiasis are suspected. Gallstones may occur; consider periodic monitoring.
Hyperglycemia and Hypoglycemia: Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly.
Most Common Adverse Reactions (>10%) include abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.
Immunogenicity: There is potential for immunogenicity.
Drug Interactions
Insulin and Oral Hypoglycemic Drugs: Blood glucose levels should be monitored and antidiabetic treatment should be adjusted accordingly.
Cyclosporine: Lanreotide Injection may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed.
Bromocriptine: Lanreotide may increase the absorption of bromocriptine.
Bradycardia-Inducing Drugs (e.g., beta-blockers): Lanreotide Injection may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary.
Drug Metabolism Interactions: Avoid other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine). Drugs metabolized by the liver may be metabolized more slowly during Lanreotide Injection treatment; dose reductions of the concomitantly administered medications should be considered.
Use in Specific Populations
Pregnancy: The risk of major birth defects and miscarriage is unknown.
Lactation: Advise women not to breastfeed during treatment with Lanreotide Injection and for 6 months following the last dose.
Females and Males of Reproductive Potential: Lanreotide Injection may reduce fertility in females of reproductive potential.
Geriatric Use: Dose selection for an elderly patient should be cautious.
You may report side effects to the FDA at 1-800-FDA-1088 or fda.gov/medwatch. You may also report side effects to Cipla at 1-866-604-3268.
Please see the full Prescribing Information for additional Important Safety Information.
