FOTIVDA 1340 MICROGRAMSHARD CAPSULES - patient leaflet, side effects, dosage

The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor. Tivozanib reduces the supply of

blood to the cancer, which slows down the growth and spread of cancer cells. It works by

a protein called vascular endothelial growth factor (VEGF) of new blood vessels.

blocking the action of

. Blocking the action of VEGF prevents the formation

Fotivda is u sed to t reat a dults with a dvanced k idney c ancer. It is u sed where other t reatments such a s interfe ron-

alpha or interleukin-2 have either not yet been used or ha

ve not helped to stop your disease.

Do not take Fotivda:

• If you are allergic to tivozanib or any of the other ingredients of this medicine (listed

If you are taking St

John’s Wort (also known as Hyp

treatment of depression and anxiety).

Warnings and precautions

in section 6);

ericum perforatum , a herbal remedy used for

Talk to your doctor, pharmacist or nurse before taking Fotivda:

• if you have high blood pressure.

Fotivda can increas is too high, may eit

e your blood pressure. Your doctor will monitor your blood press

ure regularly and, if it

her give you a medicine to lower it, or reduce your dose of Fotivda. However, if your

blood pressure remains too high, your doctor may decide to interrupt or to stop treatment with Fotivda. If

you are already taki

ng a medicine to treat high blood pressure, and your doctor reduces the dose of

Fotivda or interrupts or stops treatment, you will be

if you have or have blood vessel wall.

if you have had pro Treatment with Foti

regularly checked for low blood

had an aneurysm (enlargement and weakening of a blood vessel

pressure.

wall) or a tear in a

blems with blood clots.

ivda may raise the risk of developing a blood clot (thrombus) in your blood vessels that

could break loose and be carried by the blood stream to block another blood vessel Tell your doctor if you have ever had one of the following:

a blood clot in your lungs (with cough, chest pain, sudden shortness of breath or coughing up blood), blood clot in your legs or arms, eye, or brain (with pain or swelling in your hands or feet, reduced

Liver problems

If you have liver problems , your doctor may reduce how often you take your dose to every other day (i.e. one 1340 microgram capsule every other day).

Taking with food and

drink

Fotivda must be taken whole. Do not chew, d

with a glass of water and can be taken either with or without food. Swallow the capsule issolve or open the capsule before swallowing.

If you take more Fotivda than you should

Tell your doctor straightaway if you have taken more than your prescribed dose of 1 capsule per day.

Taking too much Fotivda makes side effects more likely or to become more severe, esp

pressure. Get medical

help straightaway if you experi

headaches. These are all symptoms of high blood pressure.

ience confusion, changes in your

ecially high blood mental state or

If you forget to take Fotivda

If you have missed taki usual time.

Do not take a double d

If you vomit after takin usual time.

ng a capsule do not take a repla

cement capsule. Continue to take your next dose at the

dose to make up for a forgotten g Fotivda, do not take a replace

If you stop taking Fotivda

Pharma

capsule.

ment capsule. Continue to take your next dose at the

Do not stop taking this medicine unless your doctor tells you to. If you stop taking the capsules your condition

may get worse.

If you have any further

questions on the use of this medicine, ask your doctor, pharmaci

Like all medicines, this

Serious side effects

medicine can cause side effects

High blood pressure is the most serious and a very co

Precautions ”). __

st or nurse.

although not everybody gets th

em.

mmon side effect (see also in section 2 “ Warnings and

Tell your doctor immediately if you think you have high blood pressure. Symptoms in

blurred vision, shortness of breath, changes in your me

disorientated

Your doctor will check

ntal state, such as feeling anxiou

clude severe headaches, s, confused or

your blood pressure regularly during treatment with Fotivda. If you develop high blood

pressure, your doctor may prescribe a medicine to treat your high blood pressure, lowe

or stop your treatment

Other side effects

with Fotivda.

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

Diarrhoea

Loss of appetite; Headache Difficult breathin Tiredness; unusu tumour).

weight loss.

r your dose of Fotivda,

g; shortness of breath during exercise; coughing.

al weakness; pain (including in the mouth, bone, extremities, side of the body, groin,

Inflammation of the mouth; slight mouth pain or discomfort; feeling sick; pain, discomfort and tightness in the stomach.----

• Hand-foot-syndrome with skin reddening, swellin
• Back pain
• Tiredness and lack of energy.

Common (may affect up to 1 in 10 people)

g, numbness and skin peeling on palms and soles.

Underactive thyr

oid gland which may cause symptoms such as tiredness, lethargy, muscle weakness, slow

o o o o o o o o o

vision, or changes in your mental state) a stroke, or signs and symptoms of a ‘mini-stro a heart attack

high blood pressure

diabetes

major surgery

ke’ (transient ischaemic attack)

multiple injuries such as broken bones and damage to internal organs

inability to move for a long period

heart failure which can cause shortness of brea inability to breathe, bluish colour on your skin,

altered consci sweating.

th or ankle swelling fingertips or lips, restlessness, anxiety, confusion,

iousness or sense of awareness, rapid, shallow breathing, a racing heart or excessive

if you suffer or have suffered from any of these symptoms or are treated for heart fa

o o o o o

Shortness of b

reath (dyspnoea) when you exert yourself or when you lie down

Feeling weak and tired

Swelling (oedema) in your legs, ankles and feet Reduced ability to exercise

Persistent cou

gh or wheezing with white or pink blood-tinged phlegm

Signs and symptoms of heart failure will be monitor

lure:

ed whilst you are taking your me

your doctor may reduce your dose of Fotivda, or interrupt or stop this treatment.

dicine. If necessary,

If you have or are treated for an abnormal rate and

rhythm of the heartbeat (arrhythmia). Your doctor

will monitor the effect of Fotivda on your heart by recording the electrical activity of

electrocardiogram) treatment.

or by measuring your blood calcium, magnesium and potassium

your heart (an levels during your

if you have problems with your liver.

Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda

(e.g. with blood tes

ts), and if necessary may need to reduce how often you take Foti

ivda.

if you have problems with your thyroid gland or use medicines to treat thyroid disease.

Treatment with Foti regularly monitor h with blood tests).

ivda may cause your thyroid glan

ow well your thyroid gland is wo

d to work less well than usual. Your doctor will

rking before and during treatment with Fotivda (e.g.

• Talk to your doctor, pharmacist or nurse while taking Fotiv if you get shortness of breath or ankle swelling

da:

Tell your doctor right away as these may be symptoms of heart failure. Your doctor will monitor this, and

depending on the severity may reduce your dose of Fotivda, or interrupt or stop tre

atment with Fotivda.

if you have had pro Treatment with Foti

blems with bleeding

ivda may increase the risk of bleeding. If you get bleeding problems (with painful

swollen stomach (abdomen), vomiting blood, coughing up blood, black stools, blood in your urine,

headache or chang to be temporarily s if laboratory tests s

Your doctor will mo doctor may reduce if you suffer from a

es in your mental state), tell your doctor right away. Treatment wi topped.

how that there is protein in your urine

nitor this at the beginning and d

ith Fotivda may need

uring your treatment. Depending on the results, your

your dose of Fotivda, or interrupt or stop this treatment.

disease of the brain, called posterior reversible encephalopathy syndrome (PRES)

Tell your doctor right away if you have symptoms such as headache, seizure (fit), lack of energy, confusion,

blindness or other visual and neurologic disturbances such as weakness in an arm or diagnosed, your doctor will stop treatment with Fotivda.

a leg. If PRES is

if the skin on the palms of your hands and the sol peeling, or is stinging or tingling _____________­_______

These may be symptoms of a condition called hand

les of your feet become dry, cra

cked, scaling, or

and, depending on treatment.

the severity, the doctor may red

foot skin reaction. Your doctor will treat the condition uce your dose of Fotivda, or interrupt or stop this

if you have symptoms of gastrointestinal perforation or fistula formation (develop

stomach or intestine or abnormal passages forming

ing a hole in the

between parts of the intestine) such as severe

stomach pain, chills, fever, nausea, vomiting or painful bowel obstruction, diarrhoea

or rectal bleeding.

Your doctor will regularly monitor you for these symptoms during your treatment with Fotivda.

if you need to have Your doctor may re

an operation or another form of surgery

commend that you temporarily stop taking Fotivda if you have an operation or surgery,

as it could affect wound healing.

The printing ink used on the Fotivda 890 microgram caps reactions.

ule contains tartrazine (E102), which may cause allergic

Children and adolescents

Do not give Fotivda to children and adolescents under 18 years of age. This medicine has children and adolescents.

not been studied in

Other medicines and Fotivda

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and other medicines you have bought without a prescription.

Fotivda may work less well when taken with some medicines. Tell your doctor if you are taking any of the

following medicines; they

may decide to change your medication:

dexamethasone (a corticosteroid to reduce inflammation and treat disorders of the immune system); rosuvastatin (a medicine used to help lower cholesterol levels in your blood);

phenobarbital, phe nafcillin, rifampicin,

nytoin, carbamazepine (used to , rifabutin, rifapentin (antibiotics)

reat epilepsy);

St. John’s Wort (also known as Hypericum perforatum , a herbal remedy used for treatment of depression

and anxiety) as this

herbal remedy should not be used at the same time as Fotivda.

Pregnancy, breast-feeding and fertility

Do not take Fotivda if you are pregnant. Tell your doctor who will discuss with you the risks of taking

Fotivda to you and Both you and your contraceptives (the

your child.

partner must use effective contraception. If you or your partne

r are taking hormonal

treatment and for a

pill, an implant or patch) you must use an additional barrier method throughout nother month after completing treatment.

Do not breast-feed during treatment with Fotivd

Fotivda passes into Talk to your doctor

breast-milk. Talk to your doctor when planning a baby, as Fotivd

a , as it is not known whether the if you are already breast-feeding a may affect the fertility of men

active ingredient in

and women.

Driving and using machii

nes

Fotivda can have side effects that may affect your ability to drive or use machines. Avoid driving or using machines if you feel weak, tired, or dizzy. See also Section 4 “Possible side effects”.

Always take this medicine exactly as your doctor has told not sure.

you. Check with your doctor or pharmacist if you are

Recommended dose

The recommended dose

is one Fotivda 1340 microgram capsule, taken once daily for 21 days (3 weeks),

followed by a 7-day (1-week) period when no capsules are taken.

This schedule is repeated

in cycles of 4 weeks.

Your doctor will check yo

7 days (1 week)

No capsules are taken

you do not suffer unacceptable side effects.

u regularly, and you will normally continue to take Fotivda as long as it is working, and

Reduced dose

In case you experience severe side effects, your doctor m the dose to:

One Fotivda 890 microgram capsule, taken once daily for

ay decide to interrupt Fotivda therapy and/or lower

period when no capsules This schedule is repeated

are taken.

in cycles of 4 weeks.

21 days (3 weeks), followed by a 7-day (1-week)

Front

heart rate, weight gain.

Unable to sleep.

Nerve damage including numbness, pins and needles, sensitive skin or numbness arms and legs.

Sight problems including blurred vision.

and weakness in the

Rapid heart rate; (blood vessel). Blood clot in the blood.

tightness of the chest; heart attack/reduced blood flow to heart

lung. Symptoms include cough,

chest pain, sudden shortness of

blood clot in an artery

breath or coughing up

Blood clot in a deep vein such as in the leg.

Very high blood

pressure leading to a stroke; flus

hed skin.

Nose bleed; runny nose; blocked nose.

Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stoma tongue; inflamed painful and/or bleeding gums.

ch; swollen and painful

Taste changes or

loss of taste.

Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).

Bleeding, e.g. in adrenal gland.

the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals, anus,

Coughing up blood; vomiting up blood. Paleness and tiredness from excess bleeding. Being sick; indigestion; constipation; dry mouth.

Itchy skin; rash; i and body; acne.

ching of the body; skin peeling;

Fever; chest pain; swelling of feet and legs; chills Joint pain; muscle pain.

Increased amount of protein in the urine.

Abnormal blood

dry skin; hair loss; redness of the skin including the hands

and low body temperature.

test results for liver, pancreas, ki

dney, and thyroid.

• Inflammation of the pancreas causing severe stomach pain which may spread to y Uncommon (may affect up to 1 in 100 people)

Rashes with pus;

fungal infections.

Bruising easily, bleeding into the skin. overactive thyroid gland (which may cause sympt

heat, increased s

weating, tremors, rapid heart rate); enlarged thyroid gland.

Increase in number of red blood cells.

Memory loss.

Temporary reduced blood flow to the brain.

Watery eyes. Blocked ears.

Lack of blood flo Peptic ulcer in th

our back.

oms like increased appetite, loss of weight, intolerance to

w through the heart blood vessels. e small intestines.

Red, swollen and sore skin; blistering skin; excessive sweating; hives.

Muscle weakness.

Swelling or irritation of the mucous membranes.

Abnormal electrocardiogram (ECG), rapid and/or irregular heart beat.

Heart failure. Symptoms include shortness of breath or ankle swelling. Swelling in

build-up.

Rare (may affect up to

1 in 1,000 people)

Posterior reversible encephalopathy syndrome (P

the lungs caused by fluid

RES). Symptoms include headac

energy, confusion, blindness or other visual and neurologic disturbances.

Not known

• An enlargement

artery dissections).

and weakening of a blood vessel wall or a tear in a blood vessel

Reporting of side effects

he, seizure, lack of

wall (aneurysms and

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not

listed in this leaflet. Yo

u can also report side effects directly via the Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medici

ne after the expiry date which is

date refers to the last day of that month.

Keep the bottle tightly closed in order to protect from

stated on the carton and bottle after EXP. The expiry

moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away

medicines you no long

er use. These measures will help

protect the environment.

What Fotivda contain: Fotivda 890 microgra i

m hard capsules

The active substance is tivozanib. Each capsule contain 890 microgram of tivozanib.

The other ingredients are:

s tivozanib hydrochloride monohydrate equivalent to

Capsule content :

mannitol, magnesium stearate.

Capsule shell : gelatin, titanium dioxide (E171), in

digo carmine (E132), yellow iron

oxide (E172).

Printing ink, yellow : shellac, propylene glycol, strong ammonia solution, titanium dioxide (E171), tartrazine

aluminium lake (E102).

Printing ink, blue : shellac, propylene glycol, stron

(E132).

Fotivda 1340 microgra

m hard capsules

g ammonia solution, indigo carmine aluminium lake

The active substance is tivozanib. Each capsule contain 1340 microgram of tivozanib.

The other ingredients are:

is tivozanib hydrochloride monohydrate equivalent to

Capsule content :

mannitol, magnesium stearate.

Capsule shell : gelatin, titanium dioxide (E171), yellow iron oxide (E172).

– Printing ink, blue : shellac, propylene glycol, stron (E132).

g ammonia solution, indigo carmine aluminium lake

yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body.

opaque cap and bright yellow o

paque body, printed with

Fotivda 1340 microgra

m hard capsules have a bright yellow opaque cap and bright yell

low opaque body, printed

with dark blue ink “TIVZ” on the cap and with dark blue ink “SD” on the body.

Fotivda 890 microgram and Fotivda 1340 microgram are available as packs of 21 capsules in HDPE-bottles with child-resistant closure.

Marketing Authorisation Holder

EUSA Pharma (UK) Limited, Breakspear Park, Breakspe

ar Way, HP2 4TZ Hemel Hempstead, United Kingdom

Manufacturer

Almac Pharma Services (Ireland) Limited, Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland.

This leaflet was last a

pproved in MM/2021.

LEA/FOT/UK/1221/01

PXXXXX/XX

EUSAPharma

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