Somatuline Depot: Adult Dosing

Dosage forms: SC

acromegaly

60-120 mg SC q4wk

Start: 90 mg SC q4wk x3mo; Info: adjust dose based on GH and IGF-1 levels

renal dosing

see below

mod-severe impairment: start 60 mg q4wk

hepatic dosing

see below

mod-severe impairment: start 60 mg q4wk

Somatuline Depot: Peds Dosing

This information is currently unavailable or not applicable for this drug.

Somatuline Depot: Contraindications/Cautions

• hypersens. to drug/class/compon.
• caution if diabetes mellitus
• caution if hypothyroidism
• caution if bradycardia
• caution if impaired renal fxn, mod-severe
• caution if impaired liver fxn, mod-severe

Somatuline Depot: Drug Interactions

Contraindicated

• cisapride

• pimozide

Monitor/Modify Tx

• amlodipine/A2R blocker combos

• amlodipine/atorvastatin

• beta blocker/thiazide combos

• beta blockers, systemic

• CCBs, dihydropyridines

• cyclosporine

• diltiazem

• hypoglycemics, other

• insulins

• metformin/sulfonylurea combos

• niacin/lovastatin

• niacin/simvastatin

• pramlintide

• sirolimus

• sulfonylureas

• tacrolimus

• theophyllines

• thiazolidinediones

• verapamils

• warfarin

Caution Advised

• acetaminophen/tramadol

• alfentanil

• alprazolam

• bortezomib

• bromocriptine

• carbamazepine

• clozapine

• colchicine

• conivaptan

• disopyramide

• dofetilide

• eletriptan

• eplerenone

• fentanyl

• lapatinib

• methadone

• midazolam

• propafenone

• quinidine

• sildenafil

• statins, 3A4 substrates

• sufentanil

• sunitinib

• tadalafil

• temsirolimus

• tramadol

• triazolam

• vardenafil

Somatuline Depot: Adverse Reactions

Serious Reactions

• cholelithiasis
• gallbladder sludge
• hyperglycemia
• hypoglycemia
• hypothyroidism (rare)
• bradycardia
• HTN
• anemia

Common Reactions

• diarrhea
• cholelithiasis
• abdominal pain
• nausea
• injection site rxn
• constipation
• flatulence
• vomiting
• arthralgia
• headache
• loose stools
• bradycardia
• weight loss
• anemia
• HTN

Somatuline Depot: Safety Monitoring

Pregnancy: C

Lactation: Safety Unknown

Monitoring Parameters: blood glucose at baseline and after dose changes; TSH as clinically indicated

Somatuline Depot: Pharmacology

Metabolism: liver; CYP450: possible 3A4 inhibitor

Excretion: urine <5%, feces (<0.5% unchanged); Half-life: 23-30 days

Class: Other Endocrine/Metab.

Mechanism Of Action
inhibits multiple hormones including growth hormone, insulin-like growth factor-1, insulin, and glucagon (somatostatin analog)

Somatuline Depot: Manufacturer/Pricing

Manufacturer: Tercica, Inc. DEA/FDA: Rx

Somatuline Depot: Patient Education

• Generic Name: lanreotide

• Pronounced: lan REE oh tide

• Brand Name: Somatuline Depot

What is the most important information I should know about lanreotide?

Before using lanreotide, tell your doctor if you have diabetes, gallbladder disease, heart disease or a heart rhythm disorder, thyroid problems, kidney disease, or liver disease. Tell your doctor if you are allergic to latex or natural rubber.

Lanreotide is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Each prefilled syringe of lanreotide is for one use only. After giving your injection, throw away used the used needle and syringe in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious side effects of lanreotide include slow or uneven heartbeats, pain in your upper right stomach with nausea and vomiting, pale skin, weakness, easy bruising or bleeding, low blood sugar (confusion, weakness, sweating, tremor, nausea), or high blood sugar (increased thirst or urination, loss of appetite, fruity breath odor, dry skin).

What is lanreotide?

Lanreotide is a man-made protein that is similar to a hormone in the body called somatostatin. Lanreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.

Lanreotide is used to as a long-term treatment in people with acromegaly who cannot be treated with surgery or radiation.

Lanreotide is sometimes given when surgery or radiation treatments have been tried without successful treatment of symptoms.

Lanreotide may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using lanreotide?

Before using lanreotide, tell your doctor if you are allergic to any drugs, or if you have:

• diabetes;
• gallbladder disease;
• heart disease or a heart rhythm disorder;
• thyroid problems;
• kidney disease;
• liver disease; or
• if you are allergic to latex or natural rubber.

If you have any of the conditions listed above, you may not be able to use lanreotide, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether lanreotide passes into breast milk. Do not use lanreotide without telling your doctor if you are breast-feeding a baby.

How should I use lanreotide?

Lanreotide should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not use lanreotide for longer than your doctor has prescribed.

Lanreotide is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Each prefilled syringe of lanreotide is for one use only. After giving your injection, throw away used the used needle and syringe in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication in its sealed pouch in the refrigerator, protected from light. Do not allow the medication to freeze.

To reduce discomfort from your injection, take the pouch out of the refrigerator about 30 minutes before using the medication. Allow the medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. Keep the pouch sealed until you are ready for your injection.

What happens if I miss a dose?

Lanreotide is usually given every 4 weeks for 3 months at a time. Contact your doctor for instructions if you miss an appointment for your lanreotide injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of lanreotide is not expected to produce life-threatening side effects.

What should I avoid while using lanreotide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lanreotide.

What are the possible side effects of lanreotide?

Stop using lanreotide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow or uneven heartbeats;
• gallbladder problems (pain in your upper right stomach area with nausea and vomiting);
• thyroid problems (may be detected by blood tests);
• pale skin, weakness, easy bruising or bleeding;
• low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or
• high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin).

Less serious side effects may include:

• nausea, vomiting;
• diarrhea, constipation;
• mild stomach pain or gas;
• headache;
• weight loss;
• joint pain; or
• pain, itching, or skin lump where injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect lanreotide?

Before using lanreotide, tell your doctor if you are taking any of the following medicines:

• cyclosporine (Neoral, Sandimmune, Gengraf);
• bromocriptine (Parlodel);
• diabetes medication such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others; or
• a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren).

This list is not complete and there may be other drugs that can interact with lanreotide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about lanreotide.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Somatuline Depot: Pill Pictures

This information is currently unavailable or not applicable for this drug.