Apo-Pomalidomide: Uses, Side Effects and Dosage

Serious Warnings and Precautions

APO-POMALIDOMIDE should only be prescribed by a doctor experienced in the use of anti- cancer drugs and registered with the ApoSecure™ controlled distribution program.

Serious side effects may occur with the use of APO-POMALIDOMIDE and could include:

• birth defects (deformed babies) or death of an unborn baby and spontaneous abortion
• decrease in the production of blood cells resulting in very low levels of white blood cells (neutropenia) and of platelets (thrombocytopenia)
• infections, which can be life-threatening
• blood clots in the veins (Deep Vein Thrombosis) and in the lung (Pulmonary Embolism)
• liver problems. Treatment with APO-POMALIDOMIDE may lead to a higher risk of liver problems which may cause death
• severe allergic reaction called anaphylaxis
• reactivation of Hepatitis B. This is when a previous viral infection of the liver becomes active again. This can be life threatening.
• severe skin reactions, which can be life threatening. These can include Stevens- Johnson syndrome, toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS).
• tumor lysis syndrome. This is caused by the fast breakdown of cancer cells. When this happens they release their contents, leading to higher or lower levels of certain other chemicals in your blood.

APO-POMALIDOMIDE is only available under a controlled distribution program called ApoSecure™.

What APO-POMALIDOMIDE is used for:

APO-POMALIDOMIDE is used to treat adults with multiple myeloma. This is a cancer of plasma cells (a type of white blood cell found in the bone marrow).

APO-POMALIDOMIDE is either used with

• dexamethasone and bortezomib for patients who:

  • have already had at least one prior treatment regimen including lenalidomide, and
  • had their disease worsen on their last treatment.

Or

• dexamethasone for patients whose disease has gotten worse after at least two other treatments including lenalidomide and bortezomib.

How APO-POMALIDOMIDE works:

APO-POMALIDOMIDE works in the bone marrow. It stimulates the immune system to attack the growth of cancerous myeloma cells. APO-POMALIDOMIDE can also slow down the growth of cancer cells.

APO-POMALIDOMIDE when used with dexamethasone and/or bortezomib can stop multiple myeloma from getting worse.

The ingredients in APO-POMALIDOMIDE are:

Medicinal ingredients: pomalidomide

Non-medicinal ingredients:

Each capsule contains Magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch.

The capsule shell contains the following non-medicinal ingredients: FD&C blue #2, gelatin, iron oxide red (2 mg), iron oxide yellow (1 mg, 2 mg, 3 mg), titanium dioxide.

The edible white ink on the capsule shells contains the non–medicinal ingredients: povidone, propylene glycol, shellac, sodium hydroxide, titanium dioxide.

The edible Black ink on the capsule shells contains the non–medicinal ingredients: iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.

APO-POMALIDOMIDE comes in the following dosage forms:

Capsules: 1 mg, 2 mg, 3 mg, and 4 mg

Do not use APO-POMALIDOMIDE if:

• You are pregnant

• You are at risk of becoming pregnant
• You become pregnant during APO-POMALIDOMIDE treatment
• You are breastfeeding
• You are a male patient and are unable to follow or comply with the contraceptive measures of the ApoSecure™ Program
• You are allergic to pomalidomide, lenalidomide or thalidomide or any of the other ingredients in APO-POMALIDOMIDE

Female patients who can get pregnant should not take APO-POMALIDOMIDE unless all conditions of the ApoSecure™ program are met.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-POMALIDOMIDE. Talk about any health conditions or problems you may have, including if you:

• are pregnant or are planning to get pregnant
• are breastfeeding
• have blood problems
• have or have had heart problems (heart attack or an irregular heartbeat)
• smoke, have high blood pressure or high cholesterol levels
• have had previous hepatitis B infection.
• have liver problems
• have had an organ transplant

Other warnings you should know about:

APO-POMALIDOMIDE may cause birth defects. In order to take this drug you must meet the following conditions:

1. 1.

   Females who can get pregnant:

   • Discuss birth control with your healthcare professional.
   • Use at least two effective methods of birth control at the same time.

   • Use these two effective methods of birth control:

     • For at least 4 weeks before starting APO-POMALIDOMIDE treatment
     • During interruptions of APO-POMALIDOMIDE treatment
     • During APO-POMALIDOMIDE treatment
     • For at least 4 weeks after stopping APO-POMALIDOMIDE treatment

   • You must have two negative pregnancy tests before starting treatment:

     • The first 7 to 14 days prior to starting treatment
     • The second within 24 hours of starting treatment.

   • You must have negative pregnancy tests during treatment:

     • Once weekly for the first 4 weeks
     • Once every 4 weeks (or once every 2 weeks if your period is irregular) for the duration of treatment and during treatment interruption
   • You must have a final pregnancy test 4 weeks after stopping APO-POMALIDOMIDE.

Any method of birth control can fail. Contact your doctor immediately if you think you may be pregnant. Be sure to also contact your doctor if you miss your period or experience unusual menstrual bleeding.

1. 2.

   Males:

   • APO-POMALIDOMIDE is present in the sperm of males who take this drug. Use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant. This must be done even if you have undergone a successful vasectomy. The condom must be used while:

     • You are taking APO-POMALIDOMIDE
     • During interruptions of treatment
     • For 4 weeks after stopping APO-POMALIDOMIDE
   • Do not donate sperm while taking APO-POMALIDOMIDE and for 4 weeks after stopping APO-POMALIDOMIDE.

   • Inform your sexual partner who can get pregnant that:

     • You are taking APO-POMALIDOMIDE
     • There is a risk of birth defects, stillbirths, and spontaneous abortions if a fetus is exposed to your sperm
     • You must use a condom

Contact your doctor immediately if you think your female partner becomes pregnant while you are taking APO-POMALIDOMIDE.

1. 3.

   All Patients:

   • Do not give blood while you take APO-POMALIDOMIDE and for at least 4 weeks after stopping APO-POMALIDOMIDE
   • Do not share APO-POMALIDOMIDE with other people
   • Do not take APO-POMALIDOMIDE if you are not enrolled in or do not meet the requirements of the ApoSecure™ controlled distribution program

APO-POMALIDOMIDE is not recommended for use in children under 18 years of age.

Driving and using machines: Before you perform tasks that may require special attention, wait until you know how you respond to APO-POMALIDOMIDE. APO-POMALIDOMIDE may cause confusion, fatigue, depressed level of consciousness, and dizziness. If you feel dizzy or tired, do not drive or use tools or machines.

Risk of Other Cancers: During treatment with pomalidomide (the medicinal ingredient in APO-POMALIDOMIDE), some other cancers have been reported. Your healthcare professional will monitor you for the signs of some cancers.

Blood Tests: You will have blood tests before starting treatment with APO-POMALIDOMIDE and regular blood tests during your treatment. Your blood will be tested once every week during your first 8 weeks of treatment, and at least monthly after that. Your healthcare professional may adjust your dose of APO-POMALIDOMIDE or interrupt your treatment based on the results of these tests and on how you are feeling.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. It is possible that APO-POMALIDOMIDE and other medicines may affect each other causing serious side effects.

The following may interact with APO-POMALIDOMIDE:

• Fluvoxamine, a drug used to treat depression and obsessive-compulsive disorder (OCD)
• Hormonal Replacement Therapy
• Hormonal Birth Control (estrogens and progestins)

Smoking can make treatment with APO-POMALIDOMIDE less effective.

How to take APO-POMALIDOMIDE:

• Take APO-POMALIDOMIDE exactly as prescribed.
• Swallow capsules whole with water once a day. Take your dose at about the same time each day.
• Do not break, chew, or open your capsules.
• If you have kidney problems and are receiving hemodialysis, take your APO-POMALIDOMIDE after hemodialysis, on hemodialysis days.
• Females who could become pregnant, or who plan to become pregnant must only handle APO-POMALIDOMIDE capsules if they are wearing latex gloves. This is important to remember for anyone helping you with your medication.

Usual adult dose:

Starting dose for APO-POMALIDOMIDE in combination with dexamethasone and bortezomib: 4 mg by mouth, once per day on days 1 to 14 of each 21 day cycle.

Starting dose for APO-POMALIDOMIDE in combination with dexamethasone alone: 4 mg by mouth, once per day on days 1 to 21 of each 28 day cycle.

Your starting dose of APO-POMALIDOMIDE may be different. This will happen if you:

• have liver problems; or
• have kidney problems and are receiving hemodialysis; or
• are taking certain medicines.

Your doctor may change your dose during treatment. Your doctor will also decide how long you need to take APO-POMALIDOMIDE. It will depend on your response to the treatment.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-POMALIDOMIDE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If less than 12 hours have passed since missing a dose, take the dose. If more than 12 hours have passed since missing a dose at the normal time, do not take the dose. Take the next dose at the normal time on the following day. Do not take 2 doses at the same time.

Possible side effects from using APO-POMALIDOMIDE:

These are not all the possible side effects you may feel when taking APO-POMALIDOMIDE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

• tiredness
• rash, itching
• fever
• flu (influenza), nose, throat and sinus infections
• swelling of arms or legs
• changes in taste (dysgeusia)
• inflammation of mouth and lips (stomatitis)
• diarrhea, nausea, constipation, vomiting, loss of appetite, indigestion (dyspepsia), bloating (abdominal distension)
• weight loss
• abdominal pain, pelvic pain, back pain, chest pain, muscle spasm
• falls
• difficulty breathing / breathlessness (dyspnea)
• cough
• dizziness
• headache
• tremor
• difficulty sleeping

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature 15°C - 30°C.

Keep out of reach and sight of children.

If you want more information about APO-POMALIDOMIDE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Date of Authorization: 2026-04-02