wedenPolivy - Vedotin uses, dose and side effects

Polivy is used to treat “diffuse large-cell B-cell lymphoma” that has returned or has not improved with at least one previous treatment and when you cannot have a stem cell transplant.

Diffuse large-cell B-cell lymphoma is cancer that develops from B-lymphocytes, also called B-cells. These are a type of blood cells.

How does Polivy work?

The active substance in Polivy is made from a monoclonal antibody bound to MMAE which is a substance that can kill cancer cells. The monoclonal antibody portion of the drug attaches to a target on the B cells. Once attached to the B cells, the drug MMAE is released into the B cells and kills them.

What other medicines is Polivy given with

Polivy is given in combination with two other anticancer medicines called rituximab and bendamustine.

What you need to know before using Polivy

Do not use Polivy

if you are allergic to elotuzumab vedotin or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before receiving Polivy.

Warnings and cautions

Talk to your doctor or nurse before using Polivy if any of the following apply to you (or you are not sure):

you have or have had cognitive or neurological problems such as:
- memory problem
- difficulty moving or sensations in the body such as tingling, burning sensation, pain or discomfort even with a light touch
- vision problem
you have or have had liver problems
you think you have an infection or have had a long-term or recurrent infection such as herpes (see “Infections” in section 4)
If you are going to be vaccinated or you know you may need a vaccination soon.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before getting Polivy.

Be aware of the following side effects

Polivy can cause serious side effects that you need to tell your doctor or nurse immediately. These include:

Myelosuppression

Myelosuppression is a condition in which the production of blood cells decreases, leading to fewer red blood cells, white blood cells, and platelets. Your doctor will take blood samples to check the number of blood cells.

Tell your doctor or nurse immediately if you:

may chill or tremble
have fever
have a headache
feeling tired
feel dizzy
looks pale
gets unusual bleeding, bruises under the skin bleed longer than usual after blood sampling, or bbleedfrom the gums.

Peripheral neuropathy

Tell your doctor or nurse immediately if you have problems with altered sensation in the skin, especially in the hands or feet, for example:

numbness
knitting
a burning sensation
pain
discomfort or weakness

If you have had any of these symptoms before treatment with Polivy, contact your doctor immediately if you notice any changes in your symptoms.

If you have symptoms of peripheral neuropathy, your doctor may lower your dose.

Infection is

Signs and symptoms of infection vary between individuals. Tell your doctor or nurse immediately if you develop symptoms of infection such as:

fever
cough
chest pain
fatigue
painful rash
sore throat
burning pain when urinating
feel weak or generally ill.

Progressive multifocal leukoencephalopathy (PML)

PML is a very rare and life-threatening infection of the brain, which has occurred in a patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.

Tell your doctor or nurse immediately if you get:

memory loss
speech difficulties
difficulty walking
vision problem.

If you have had any of these symptoms before treatment with Polivy, contact your doctor immediately if you notice any changes in your symptoms. You may need medical treatment.

Tumor light syndrome

Some people may develop abnormal levels of certain substances (such as potassium and uric acid ) in the blood caused by the rapid breakdown of cancer cells during treatment. This is called tumor light syndrome. Your doctor or nurse will take blood samples to check the risk of this condition.

Infusion-related reactions

Infusion-related reactions and allergic or anaphylactic (more severe allergic) reactions may occur. Your doctor or nurse will observe if you get any side effects during the infusion and for 30 to 90 minutes after the end of the infusion. If you get a severe reaction, your doctor may stop taking Polivy.

Liver damage

This medicine can cause inflammation or damage the cells in the liver that affect the normal functioning of the liver. Damaged liver cells can leak large amounts of certain substances (liver enzymes and bilirubin ) into the bloodstream, which can be detected with blood tests.

In most cases, you do not get any symptoms, but tell your doctor or nurse immediately if you get:

yellowing of the skin and the whites of the eyes (jaundice)

Your doctor will take blood samples to check your liver function before and regularly during treatment.

Children and young people

This medicine should not be used in children or adolescents under 18 years of age. This is because there is no information about its use in this age group.

Other medicines and Polivy

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

This also applies to over-the-counter medicines and herbal medicines.

Pregnancy, breastfeeding, and fertility

Contraceptives (women and men)

If you are a woman of childbearing potential, you must use effective contraception during treatment and for 9 months after the last dose of one of Polivy.

Men must use contraception during treatment and for 6 months after the last dose of one of Polivy.

Pregnancy

It is important to tell your doctor before and during treatment, if you are pregnant, think you may be pregnant, or are planning to have a baby. This is because Polivy may affect your baby’s health. You should not use this medicine if you are pregnant unless you and your doctor consider it necessary and the benefit to you outweighs the potential risk to the unborn baby.

Breast-feeding

Do not breastfeed when you receive Polivy and for at least 3 months after the last dose, as small amounts of Polivy may pass into your breast milk.

Fertility

Men who are to be treated with this medicine should be advised to take sperm samples for storage before starting treatment.

Driving and using machines

Polivy has little effect on your ability to drive, cycle, and use tools or machines. If you experience infusion-related reactions or nerve damage, or if you feel tired, weak, or dizzy (see section 4), do not drive, cycle or use any tools or machines until the reaction has disappeared.

See section 4 for more information on side effects.

Polivy contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

How to use Polivy

Polivy is given under the supervision of a doctor who has experience in administering these treatments. It is given to a friend as an infusion (drip) for 90 minutes.

How much Polivy is given

The dose of one of these drugs depends on your body weight.

The usual starting dose is 1.8 mg per kg of body weight.
If you have peripheral neuropathy, your doctor may reduce your dose to 1.4 mg per kg of body weight.

You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.

Each cycle lasts for 21 days.

If you forget a dose of Polivy

If you miss a booked time, book a new time immediately. For the treatment to have full effect, it is very important not to miss a dose.

If you stop using Polivy

Do not stop treatment with Polivy unless you have discussed it with your doctor. Discontinuation of treatment may worsen your illness.

If you have any further questions on the use of this product, ask your doctor or nurse. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with this medicine:

Serious side effects are

Tell your doctor or nurse if you notice any of the following serious side effects – you may need urgent medical attention. It may be new symptoms or a change in your current symptoms.

fever and chills
skin rash/hives
serious infection you
pneumonia _ _ _
herpes infection
virus infection
unusual bleeding and bruising under the skin
memory loss, speech difficulties, difficulty walking, or vision problems
yellow skin or whites of the eyes

Other side effects:

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

Very common (may affect more than 1 in 10 people)

serious infection you
fever
cough
vomiting
pneumonia _ _ _
diarrhea or constipation
feeling sick (nausea)
abdominal pain (stomach pain)
fatigue ( anemia, anemia )
loss of appetite
weight loss
infusion-related reactions
common cold
dizziness
unusual sensations

Common (may affect up to 1 in 10 people)

overindulge
viral infections
herpes infection
difficulty walking
pneumonia
elevated liver enzymes
joint pain
itching

How to store Polivy

Polivy will be stored by healthcare professionals at the hospital or clinic. The storage conditions and handling are as follows:

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. and on the vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Keep the vial in the outer carton to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is elotuzumab vedotin.
Polivy 30 mg: Each vial contains 30 milligrams (mg) of elotuzumab vedotin.
Polivy 140 mg: Each vial contains 140 milligrams (mg) of elotuzumab vedotin.
After reconstitution, each milliliter (ml) contains 20 mg of elotuzumab vedotin.
The other ingredients are succinic acid, sodium hydroxide, sucrose, and polysorbate 20. See section “Polivy contains sodium”.

What the medicine looks like and the contents of the pack

Polivy powder for concentrate for solution for infusion is a white to slightly off-white powder (powder cake) in a glass vial.

Each pack of Polivy consists of one vial.

Marketing Authorization Holder and Manufacturer

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Registration AG