Portrazza: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Increased frequency of heart attack or sudden death
• Increased risk for blood clots in your veins or arteries
• Increased risk of low blood levels of magnesium, calcium, potassium, or phosphate

What is PORTRAZZA used for?

• PORTRAZZA is a cancer medicine used in combination with gemcitabine and cisplatin (other anti-cancer medicines) for the treatment of patients with a type of advanced lung cancer (called squamous non-small cell lung cancer) who have not received prior chemotherapy for this condition.

How does PORTRAZZA work?

• PORTRAZZA contains the active substance necitumumab, which belongs to a group of biologic substances called monoclonal antibodies.
• PORTRAZZA recognizes and binds specifically to a protein on the surface of some cancer cells. The protein is known as an epidermal growth factor receptor (EGFR). Other body proteins (called growth factors) can attach to the EGFR and stimulate the cancer cell to grow and divide. PORTRAZZA stops other proteins from binding to the EGFR and thus prevents the cancer cell from growing and multiplying.

What are the ingredients in PORTRAZZA?

• Medicinal ingredients: necitumumab
• Non-medicinal ingredients: citric acid anhydrous, glycine, mannitol, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection

PORTRAZZA comes in the following dosage forms:

• PORTRAZZA is available as a solution in 50 mL single use vials. Each vial contains 800 mg/50 mL (16 mg/mL).
• After dilution and preparation, PORTRAZZA is administered as an intravenous (I.V.) infusion.

Do not use PORTRAZZA if:

• you are allergic to this drug or to any ingredient in the formulation.

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

• have had blood clots in the veins or the arteries (‘venous thromboembolic events and arterial thromboembolic events’);
• have ever had a heart attack or stroke;
• have ever had low blood levels of magnesium, calcium, potassium or phosphate;
• have ever had an allergic reaction to an infusion;
• have ever had skin reactions after treatment with a drug;

• are pregnant or plan to become pregnant;

• are breastfeeding;
• have any allergies to this drug or to its ingredients.

Other warnings you should know about:

• Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of PORTRAZZA as this medicine may potentially cause harm to your unborn child. Talk to your doctor about the best contraception for you.
• Do not breast-feed your baby during treatment with PORTRAZZA and for at least 4 months after you receive the last dose, as this medicine may harm the growth and development of your baby.

Elderly Patients (70 years and older):

• Talk with your healthcare professional about the individual benefits and risks of adding PORTRAZZA to chemotherapy, as no apparent benefit was seen in patients 70 years of age or older. Blood clots in this age group were more frequently reported. Your healthcare professional will assess your health and discuss with you whether chemotherapy and PORTRAZZA are an appropriate option for you.

Children and adolescents:

• PORTRAZZA should not be given to patients under the age of 18 years because there is no information about how it works in this age group.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take PORTRAZZA:

• PORTRAZZA is given by intravenous infusion (through a needle placed in a vein in the arm, hand or through a central line). Each infusion lasts approximately 60 minutes.
• PORTRAZZA is given in combination with gemcitabine and cisplatin. You should read the patient information for gemcitabine and cisplatin as well. Your doctor will determine your treatment plan. Ask your doctor or health care team if you have any questions.

Usual dose:

• The recommended dose of PORTRAZZA is 800 mg on days 1 and 8 of each 3-week cycle.
• The number of infusions that you receive will depend on how and for how long you respond to treatment with PORTRAZZA. Your doctor will discuss this with you.

Premedication

• You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive PORTRAZZA.
• If you experience an infusion-related reaction during PORTRAZZA therapy, you will be given other medications to reduce or prevent such reactions for all future infusions.
• Symptoms of infusion-related reactions may include increased muscle tension, back pain, chest pain and/or tightness, chills, flushing, difficulty in breathing, wheezing, and feeling of tingling or numbness in hands or feet. In severe cases, symptoms may include breathing distress caused by narrowing of the airways, faster heartbeat, and feeling weak.

Dose Adjustments

• During each infusion, your doctor or nurse will check for side effects. The time over which your infusion is given may lengthen if you experience an infusion-related reaction during treatment.
• Depending on any side effects you have, your treatment may be stopped temporarily and/or permanently.

Overdose

Missed Dose

If you miss an infusion, contact your doctor immediately for further instructions.

What are possible side effects from using PORTRAZZA?

Tell your doctor immediately if you experience any of the following serious side effects during PORTRAZZA treatment:

• Chest pain (may or may not feel like pressure or tightness in your chest) or loss of strength in an arm or leg, change in speech or change in vision which could be due to blood clots in the arteries (can lead to a heart attack or stroke);
• Swelling, pain and tenderness in the limb which can be due to a blood clot in the vein. Blood clots can also develop in the blood vessels of the lung. Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
• Low blood levels of magnesium, potassium, calcium or phosphate. Blood samples may be taken before each infusion of PORTRAZZA to measure these electrolyte levels and to determine if supplements are required.

Tell your doctor if you experience any of the following other side effects:

Very common: may affect more than 1 in 10 people

• Skin reactions, such as acne-like rash, itchy dry skin, scaling, skin peeling, nail changes, redness on the palms of hands and feet
• Vomiting
• Fever or high temperature (pyrexia)
• Decreased weight
• Mouth ulcers
• Cold sores

Common: may affect up to 1 in 10 people

• Headache
• Coughing up blood (hemoptysis)
• Nosebleed (epistaxis)
• Strange tastes; metallic taste (dysgeusia)
• Eye reactions, such as inflammation, pink eye, irritation, blurred vision, dry eyes
• Bladder and/or kidney infection (urinary tract infection)
• Pain when passing urine (dysuria)
• Difficulty in swallowing (dysphagia)
• Muscle spasms
• Inflammation of veins in the legs (phlebitis)
• Pain in your mouth and throat (oropharyngeal pain)

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

Reporting Side Effects

Storage:

• Store PORTRAZZA in a refrigerator at 2 °C – 8 °C (36 °F – 46 °F) until time of use.
• Do not freeze or shake the vial.
• Keep the vial in the outer carton in order to protect from light.
• Keep out of reach and sight of children.

If you want more information about PORTRAZZA:

• 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; the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.

Last Revised: March 16, 2017

POR-0000-CA-PM-20170316