Apo-Nabilone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-NABILONE (nabilone) is indicated for the management of severe nausea and vomiting associated with cancer therapy.

What it does:

APO-NABILONE decreases nausea (sensation of feeling sick) and vomiting.

When it should not be used:

You should not take APO-NABILONE if:

• you have known sensitivity to marijuana or other cannabinoid agents
• you have a history of psychotic reactions
• you are under the age of 18 years

• you are breastfeeding

• you are pregnant

What the medicinal ingredient is:

The medicinal ingredient in APO-NABILONE is nabilone, a synthetic cannabinoid agent.

What the non-medicinal ingredients are:

APO-NABILONE contains the following non-medicinal ingredients: D&C red No. 33 (0.5 mg capsule), D&C yellow No. 10 (0.25 and 0.5 mg capsules), FD&C blue No. 1 (0.25 mg capsule), FD&C blue No. 2 (1 mg capsule), FD&C red No. 40 (0.25 and 0.5 mg capsules), gelatin, iron oxide red (1 mg capsule), povidone, pregelatinized starch, talc and titanium dioxide. The capsule shells are imprinted with black edible ink and contain ammonium hydroxide, iron oxide black, propylene glycol and shellac.

What dosage forms it comes in:

APO-NABILONE (nabilone) is formulated into capsules of 0.25 mg, 0.5 mg, or 1 mg strengths for oral administration.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE you use APO-NABILONE talk to your doctor or pharmacist if:

• you are taking any other prescription or non-prescription medicine, or natural/herbal remedies
• you are pregnant or breastfeeding
• you are allergic to nabilone, the main ingredient in APO-NABILONE, or any other ingredient in APO-NABILONE (see “What the non-medicinal ingredients are”)
• you have hypertension or heart problems

INTERACTIONS WITH THIS MEDICATION

While you are taking APO-NABILONE, do not start any new medicines, including natural or herbal medicines, without speaking to your doctor first. Tell your doctor about all the medicines that you are taking including those that you have bought yourself.

APO-NABILONE can interact with:

• Diazepam
• Sodium secobarbital

• Alcohol

• Codeine
• Any medicine that affects your mental and psychomotor function (e.g., causes hallucinations, weird thoughts, etc).

PROPER USE OF THIS MEDICATION

The label on the container of your medicine should tell you how often to take your medicine and how many doses you should take each time. If not, or if you are not sure, ask your doctor or pharmacist.

Do not take more doses, or take them more often than your doctor prescribes.

Your doctor prescribed APO-NABILONE for your use only. You should not let anyone else use it.

Usual Adult Dose:

You will receive APO-NABILONE prior to chemotherapy and, if necessary, after cancer treatment. Based on how likely you are to experience nausea and/or vomiting, caused by your cancer treatment, your doctor will tell you the amount you need to take and how frequently. Follow the directions provided by your doctor for using this medicine. Your doctor may also have to adjust your dose depending on how you react to APO-NABILONE.

Overdose:

Some of the signs of overdose are psychotic episodes including hallucinations, anxiety reactions, respiratory depression, and coma.

Overdose may even occur at prescribed doses. If psychiatric symptoms (e.g., weird thoughts, hallucinations, etc.) are present, contact poison control centre immediately or go to the nearest emergency room.

Missed Dose:

If you forget a dose of APO-NABILONE, you should take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double your dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Some patients may experience drowsiness, psychological high, vertigo, dry mouth, depression, ataxia, asthenia, blurred vision, sensation disturbance, anorexia, headache, orthostatic hypotension, euphoria, and hallucinations. You should tell your doctor or pharmacist about these symptoms.

If your nausea (feeling of sickness) or vomiting do not improve while taking APO-NABILONE, consult your doctor for further advice.

If you feel unwell or have any symptoms that you do not understand, you should contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking APO-NABILONE, contact your doctor or pharmacist immediately.

HOW TO STORE IT

Keep APO-NABILONE out of sight and reach of children.

Store at controlled room temperature 15°C-30°C in a tightly closed container.

Reporting Side Effects

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex’s Drug Information Service at:

1-800-667-4708

Last prepared: May 15, 2015