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Reddy-Pomalidomide Patient Medication Information

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READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION
^PrReddy-Pomalidomide
Pomalidomide Capsules

Read this carefully before you start taking Reddy-Pomalidomide and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Reddy-Pomalidomide.

Reddy-Pomalidomide can only be given to patients who are registered in and meet all conditions of the Reddy-Pomalidomide RMP program.  Reddy-Pomalidomide RMP program is a controlled distribution program of Reddy-Pomalidomide.

What is Reddy-Pomalidomide used for?

Reddy-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).

Reddy-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 does Reddy-Pomalidomide work?

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

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

What are the ingredients in Reddy-Pomalidomide?

Medicinal ingredient: pomalidomide 

Non-medicinal ingredients: anhydrous lactose, D&C Red 28 (4 mg), D&C Red 33, D&C Yellow 10 (2 mg),  FD&C Blue 1, FD&C Red 3, FD&C Red 40 (3 mg), gelatin, pregelatinized starch, sodium stearyl fumarate and titanium dioxide. 

The capsule shells are imprinted with white ink. The white ink (White ink Tek SW 0012), contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.

Reddy-Pomalidomide comes in the following dosage forms: Capsules: 1 mg, 2 mg, 3 mg, or 4 mg

Do not use Reddy-Pomalidomide if:

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

Female patients who can get pregnant should not take Reddy-Pomalidomide unless all conditions of the Reddy-Pomalidomide RMP program are met.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Reddy-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 

Other warnings you should know about: 

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

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 Reddy-Pomalidomide treatment
  • During interruptions of Reddy-Pomalidomide treatment
  • During Reddy-Pomalidomide treatment
  • For at least 4 weeks after stopping Reddy-Pomalidomide treatment

• You must have two negative pregnancy tests before starting treatment:
  • The first 7-14 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 Reddy-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.

2. Males:

• Reddy-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 Reddy-Pomalidomide
  • During interruptions of treatment
  • For 4 weeks after stopping Reddy-Pomalidomide
• Do not donate sperm while taking Reddy-Pomalidomide and for 4 weeks after stopping Reddy-Pomalidomide.
• Inform your sexual partner who can get pregnant that:
  • You are taking Reddy-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 Reddy-Pomalidomide.

3. All Patients:

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

Reddy-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 Reddy-Pomalidomide. Reddy-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 Reddy-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 Reddy-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 Reddy-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 Reddy-Pomalidomide and other medicines may affect each other causing serious side effects. 

The following may interact with Reddy-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 Reddy-Pomalidomide less effective.

How to take Reddy-Pomalidomide:

• Take Reddy-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 Reddy-Pomalidomide after hemodialysis, on hemodialysis days. 
• Females who could become pregnant, or who plan to become pregnant must only handle Reddy-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 Reddy-Pomalidomide in combination with dexamethasone and bortezomib: 4 mg by mouth, once per day on days 1-14 of each 21 day cycle. 

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

Your starting dose of Reddy-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 Reddy-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 Reddy-Pomalidomide, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no 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.

What are possible side effects from using Reddy-Pomalidomide?

These are not all the possible side effects you may feel when taking Reddy-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

Symptom/Effect		Talk to your healthcare professional		Stop taking drug and get immediate medical help
		Only if severe	In all cases
Very common	Peripheral neuropathy: numbness or tingling in feet or hands
Very common	Neutropenia, neutropenic sepsis, leukopenia, lymphopenia (low levels of white blood cells): chills, fever, sweating, any signs of infection
Very common	Anemia (low levels of red blood cells): fatigue, pale skin, shortness of breath, weakness
Very common	Thrombocytopenia (low levels of platelets in the blood): bleeding from the gums or other sites, or abnormal bleeding, bruising
Very common	Infections including chest infections, pneumonia, bronchitis, bronchial pneumonia: fever, chills, fatigue, cough, shortness of breath, coughing up thick yellow or green mucous, fast heartbeat; urinary tract infection: frequent urination, burning or painful urination, cloudy urine
Common	Bone pain
Common	Venous thromboembolism including deep vein thrombosis (blood clot in a blood vessel): pain with arm or leg swelling and redness; pulmonary embolism (blood clot in the lungs): shortness of breath, sudden chest pain or difficulty breathing
Common	Confusion
Common	Urinary retention: difficulty urinating
Common	Depressed level of consciousness: altered mental state
Common	Vertigo: dizziness, spinning sensation
Common	Cataract: clouding of the lens of the eye, blurry or dim vision, eye pain
Common	Depression: feeling sad
Common	Kidney failure: lack of urine, shortness of breath, confusion
Common	Hypotension (low blood pressure): lightheadedness, dizziness or fainting
Common	Hypertension (high blood pressure): headache, shortness of breath
Rare	Tumor lysis syndrome (the sudden, rapid death of cancer cells due to treatment): nausea, shortness of breath, irregular heartbeat, lack of urine, cloudy urine, severe muscle weakness, seizures
Rare	Allergic reactions (anaphylactic reactions, angioedema, urticaria): rapid swelling of the face, lips, tongue and throat; breathing or swallowing problems, red itchy welts on skin
Rare	Severe dermatologic reactions including Stevens-Johnson Syndrome or toxic epidermal necrolysis (rare skin reactions): peeling or blistered skin, changes in the appearance of your skin
Rare	Hepatitis / reactivation of hepatitis (inflammation of the liver): itchy skin, yellowing of skin and whites of eyes, pale coloured stools, dark coloured urine, abdominal pain
Rare	Lung disease or lung inflammation (pneumonitis): shortness of breath, dry cough, fatigue
Very Rare	Basal and squamous cell carcinoma (certain types of skin cancer): changes in the appearance of your skin or growths on your skin
Unknown	Drug reaction with eosinophilia and systemic symptoms (DRESS; rare reaction to some medicines): flu-like symptoms, rash on the face which may extend all over the body, fever
Unknown	Symptoms of Progressive Multifocal Leukoencephalopathy: vision changes, difficulty speaking, weakness in limbs, change in the way you walk or balance, persistent numbness, decreased or loss of sensation, memory loss or confusion

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.

Storage

Store Reddy-Pomalidomide at 15°C to 30°C.  Keep out of the reach and sight of children.

If you want more information about Reddy- Pomalidomide:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.drreddys.com/canada or by calling: 1-855-845-1739.

This leaflet was prepared by Dr. Reddy’s Laboratories Ltd.

Last revised: December 07, 2022