890 micrograms, 1,340 micrograms hard capsule
tivozanib

1. What Fotivda is and what it is used for

The active substance in Fotivda is the protein kinase inhibitor tivozanib. Tivozanib reduces the blood supply to cancer, which slows down the growth and spread of cancer cells. It works by blocking the effect of a protein called vascular endothelial cell growth factor (VEGF). By blocking the effect of VEGF, the development of new blood vessels is prevented.

Fotivda is used to treat adults with advanced kidney cancer. It is used when other treatments such as interferon-alpha or interleukin- 2, have not yet been used or helped to stop the disease.

2. What you need to know before using Fotivda

Do not use Fotivda

  • if you are allergic to tivozanib or any of the other ingredients of this medicine (listed in section 6);
  • if you use St. John’s wort (also called Hypericum perforatum, an herbal medicine used to treat mild depression and mild anxiety).

Warnings and cautions

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

  • If you have high blood pressure.
    Fotivda can increase your blood pressure. Your doctor will monitor your blood pressure regularly. If it is too high, your doctor will give you medicine that can lower it or reduce your Fotivda- dose. If your blood pressure continues to be too high, your doctor may decide to temporarily or permanently stop your treatment with Fotivda. If you are already taking a medicine for high blood pressure and your doctor is reducing the dose of one of Fotivda or stopping treatment temporarily or permanently, your blood pressure will be checked regularly.
  • If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall
  • If you have problems with blood clots.
    The treatment with Fotivda may increase the risk of developing a blood clot ( thrombosis ) in the blood vessels that could become detached, travel with the bloodstream, and clog another blood vessel.
    Tell your doctor if you have ever had any of the following:
    • Blood clots in the lungs (with cough, chest pain, sudden shortness of breath, or blood cough),
    • Blood clots in the legs, arms, eyes, or brain (with pain or swelling in the hands and feet, impaired vision, or altered mental state)
    • Stroke, or signs and symptoms of a “ministroke” (TIA; transient ischemic attack)
    • Heart attack
    • High blood pressure
    • Diabetes
    • Major surgery
    • Multiple injuries, e.g. broken bones and damage to internal organs
    • Could not move for a long time
    • Heart failure can cause shortness of breath or swollen ankles
    • Unable to breathe, bluish skin color, fingertips or lips, restlessness, anxiety, confusion, altered state of consciousness, rapid, shallow breathing, a shining heart, or abnormally increased sweating.
  • If you have or have had any of the following symptoms or are being treated for heart failure.
    • Shortness of breath ( dyspnoea ) when you exert yourself or when you lie down
    • The feeling of weakness and tiredness
    • Swelling ( edema ) in the legs, ankles, and feet
    • Decreased ability to exercise physically
    • Persistent cough or wheezing breathing sound with white or pink blood-colored mucus

Signs and symptoms of heart failure will be monitored as long as you take your medication. If necessary, your doctor may reduce your Fotivda dose, or stop treatment temporarily or permanently.

  • If you have or are being treated for abnormal heart rate and abnormal heart rhythm ( arrhythmia or heart rhythm disorders). Your doctor will monitor how Fotivda affects your heart by recording your heart’s electrical activity (an electrocardiogram ) or by measuring the levels of calcium , magnesium, and potassium in your blood during treatment.
  • If you have problems with your liver. Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (eg with blood tests) and, if necessary, prescribe you to take Fotivda less often.
  • If you have thyroid problems or are taking medication to treat the thyroid disease. The treatment with Fotivda can make the thyroid gland function worse than usual. Your doctor will regularly monitor how well your thyroid is functioning before and during treatment with Fotivda (eg with blood tests.

Talk to your doctor, pharmacist, or nurse when using Fotivda:

  • If you get shortness of breath or swollen ankles
    Contact a doctor immediately as it may be a symptom of heart failure. Your doctor will monitor this and depending on how serious it is, your doctor may reduce your Fotivda dose or stop treatment temporarily or permanently.
  • If you have had bleeding problems
    Treatment with Fotivda may increase the risk of bleeding. Contact a doctor immediately if you have bleeding problems (painful swollen stomach (abdomen), if you vomit blood, cough up blood, get black stools, blood in the urine, headaches, or if your mental state changes). It may be necessary to temporarily discontinue treatment with Fotivda.
  • If laboratory tests show that there is a protein in your urine
    Your doctor will monitor this at the beginning and during treatment. Depending on the results, your doctor may reduce your Fotivda dose, or discontinue treatment temporarily or permanently.
  • If you have a disease in the brain called posterior reversible encephalopathy syndrome (PRES)
    Contact a doctor immediately if you have symptoms, e.g. headache, seizures, lack of energy, confusion, blindness, or other visual or neurological disorders such as weakness in an arm or a leg. If PRES is diagnosed, your doctor will stop treatment with Fotivda.
  • If the skin on the hands or soles of the feet becomes dry, cracks, scales or comes off, or if it stings or stings
    This may be a symptom of a condition called hand-foot-skin reaction. Your doctor will treat this condition and, depending on how serious it is, the doctor may reduce your Fotivda- dose or interrupt treatment temporarily or permanently.
  • If you have symptoms of rupture of the intestine or fistula formation (a hole develops in the stomach or intestine or abnormal passages form between different parts of the intestine), e.g. severe abdominal pain, chills, fever, nausea, vomiting or constipation, diarrhea, or rectal bleeding.
    Your doctor will regularly monitor these symptoms during treatment with Fotivda.
  • If you need to have an operation or other form of surgery
    Your doctor may recommend that you temporarily stop taking Fotivda if you are going to have surgery or undergo surgery, as this may affect wound healing.

The printing ink on the capsule with Fotivda 890 micrograms contains tartrazine (E102) which may cause allergic reactions.

Children and young people

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

Other medicines and Fotivda

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

Fotivda may work less well if taken at the same time as some other medicines. Tell your doctor if you are taking any of the following medicines, as your doctor may decide to change your medication:

  • Dexamethasone (cortisone that reduces inflammation and treats disorders of the immune system);
  • Rosuvastatin (a medicine used to help lower cholesterol levels in your blood);
  • Phenobarbital, Phenytoin, Carbamazepine (used to treat epilepsy );
  • Nafcillin, Rifampicin, Rifabutin, Rifapentine ( antibiotics );
  • St. John’s wort (also called Hypericum perforatum, an herbal medicine used to treat mild depression and alleviate anxiety) because one should not use this herbal medicine at the same time as Fotivda

Fotivda with food and drink

Fotivda must be taken with a glass of water and can be taken with or without food. Swallow the capsule whole. Do not chew, dissolve or open the capsule before swallowing.

Pregnancy, breastfeeding, and fertility

  • Do not take Fotivda if you are pregnant. If you are pregnant, tell your doctor and your child about the risks of Fotivda.
  • Both you and your partner must use effective contraception. If you or your partner take hormonal contraceptives ( birth control pills, IUDs, or patches ), you must use an additional method of protection throughout the treatment and one month after the end of the treatment.
  • Do not breast-feed during treatment with Fotivda as it is not known if the active substance in Fotivda passes into breast milk. Talk to a doctor if you are already breastfeeding.
  • Talk to a doctor if you are planning to have children as Fotivda may affect male and female fertility.

Driving and using machines

Fotivda can have side effects that affect the 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.

How to use Fotivda

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

The recommended dose is one capsule of Fotivda 1,340 micrograms, once daily for 21 days (three weeks), followed by 7 days (one week) without treatment.

This schedule is repeated in four-week cycles.

Picture 1

Your doctor will check you regularly and in normal cases, you will continue to take Fotivda for as long as the treatment works and you do not get unacceptable side effects.

Reduced dose

If you experience severe side effect is the doctor may decide to interrupt Fotivda treatment and/or lowering the dose of one too:

one capsule Fotivda 890 micrograms, once daily for 21 days (three weeks), followed by 7 days (one week) without treatment.

This schedule is repeated in four-week cycles.

Liver problem

If you have liver problems, your doctor may prescribe you to take your dose every other day (ie one capsule 1,340 micrograms every other day).

If you take more Fotivda then you should

Contact a doctor immediately if you have taken more than the prescribed dose, equivalent to one capsule daily.

Too much Fotivda increases the risk of side effects or the risk of severe side effects, especially high blood pressure. Seek medical attention immediately if you experience confusion, if your mental state changes or if you get a headache. All of these are symptoms of high blood pressure.

If you forget to take Fotivda

Do not take a replacement capsule if you have missed a capsule. Take the next dose at the usual time.

Do not take a double dose to make up for a forgotten capsule.

Do not take a replacement capsule if you vomit after taking Fotivda. Take the next dose at the usual time.

If you stop taking Fotivda

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

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

4. Possible side effects

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

Serious side effects are

High blood pressure is the most serious and is a very common side effect (see also section 2 Warnings and precautions).

Contact a doctor immediately if you think you have high blood pressure. Symptoms include severe headache, blurred vision, shortness of breath, altered mental state, e.g. you feel anxiety, confusion, or feel disoriented.

Your doctor will check your blood pressure regularly during treatment with Fotivda. If you develop high blood pressure, your doctor may prescribe a medicine for high blood pressure, reduce the dose of one of Fotivda or discontinue treatment with Fotivda.

Other side effects are

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

  • Speech difficulties
  • Diarrhea
  • Lost appetite, weight loss.
  • Headache.
  • Breathing difficulties, shortness of breath during physical activity, cough.
  • Fatigue, unusual weakness, pain (including in mouth, skeleton, and arms, side of body, groin, tumor ).
  • Inflammation of the mouth, mild pain or discomfort in the mouth, nausea, pain, and discomfort in the stomach, and bloated stomach.
  • Hand-foot syndrome with reddening of the skin, swelling, numbness, and skin loosening on the palms and soles of the feet,
  • Back pain.
  • Fatigue and lack of energy.

Common (may affect up to 1 in 10 people) 

  • An underactive thyroid gland that can cause symptoms e.g. fatigue, lethargy, muscle weakness, slow heart rate, weight gain
  • Insomnia.
  • Nerve damage including numbness, tingling, sensitive skin or numbness and weakness in arms and legs
  • Vision problems including blurred vision.
  • Rapid pulse, pressure over the chest, heart attack / decreased blood flow to the heart, blood clot in an artery (blood vessel).
  • Blood clots in the lungs. Symptoms include cough, chest pain, sudden shortness of breath, or blood cough.
  • Blood clot in a deep vein in the leg.
  • Very high blood pressure leading to stroke, reddening of the skin.
  • Nasal bleeding, runny nose, stuffy nose.
  • Flatulence, heartburn, difficulty swallowing and pain when swallowing, sore throat, bloated stomach, swollen and painful tongue, inflamed, painful, and/or bleeding gums.
  • Taste change or loss of taste
  • Dizziness, ringing in the ears, dizziness, and a feeling that everything is spinning ( vertigo ).
  • Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, intestinal ulcers, female genitalia, anus, adrenal gland.
  • Cough blood, vomit blood
  • Paleness and fatigue due to bleeding
  • Nausea, indigestion, constipation, dry mouth.
  • Itchy skin, skin rash, flaking skin, dry skin, hair loss, redness of the skin including on hands and body, acne.
  • Fever, chest pain, swollen feet and legs, chills, and low body temperature.
  • Joint pain and muscle pain.
  • The increased amount of protein in the urine.
  • Abnormal blood test results for the liver, pancreas, kidneys, and thyroid gland.
  • Inflammation of the pancreas that causes severe abdominal pain that can radiate to the back.

Uncommon (may affect up to 1 in 100 people)

  • Skin rash with warts, fungal infections.
  • Increased risk of bruising, bleeding in the skin,
  • Overactive thyroid gland (which may cause symptoms such as increased appetite, weight loss, heat intolerance, increased sweating, tremors, increased heart rate ), enlarged thyroid gland.
  • Increased number of red blood cells
  • Insomnia
  • Memory loss.
  • Temporarily reduced blood flow to the brain
  • Watery eyes.
  • Clogged ears.
  • Lack of blood flow through the blood vessels of the heart.
  • Gastric ulcer in the small intestine.
  • Red, swollen and sore skin, skin blisters, increased sweating, hives.
  • Muscle weakness.
  • Swollen or irritated mucous membranes.
  • Abnormal electrocardiogram ( ECG ), fast and/or irregular heartbeat.
  • Heart failure. Symptoms include shortness of breath or swollen ankles. Swelling of the lungs due to fluid accumulation

Rare (may affect up to 1 in 1,000 people)

  • Posterior reversible encephalopathy syndrome (PRES). Symptoms include headache, cramps, lack of energy, confusion, blindness, or other visual or neurological disorders.

No known frequency

  • An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).

5. How to store Fotivda

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 and bottle after EXP. The expiration date is the last day of the specified month.

Close the bottle tightly. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

Fotivda 890 micrograms, hard capsule

The active substance is tivozanib. Each capsule contains 890 micrograms of tivozanib (as a hydrochloride monohydrate).

Other ingredients are:

  • Capsule content: mannitol, magnesium stearate.
  • Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172).
  • Printing ink, yellow: shellac, propylene glycol, strong ammonia solution, titanium dioxide (E171), tartrazine (E102).
  • Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminum lacquer (E132).

Fotivda 1,340 micrograms, hard capsule

The active substance is tivozanib. Each capsule contains 1,340 micrograms of tivozanib (as hydrochloride monohydrate).

Other ingredients are:

  • Capsule content: mannitol, magnesium stearate.
  • Capsule shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172).
  • Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminum lacquer (E132).

What the medicine looks like and the contents of the pack

Fotivda’s appearance and package sizes

The hard capsules with Fotivda 890 micrograms have a dark blue opaque top and a light yellow opaque bottom and are marked “TIVZ” on the top with yellow ink and “LD” on the bottom with dark blue ink.

The hard capsules with Fotivda 1 340 micrograms have a light yellow opaque upper part and a light yellow opaque lower part and are marked “TIVZ” on the upper part with dark blue ink and “SD” on the lower part with dark blue ink.

Fotivda 890 micrograms and Fotivda 1,340 micrograms are available in packs of 21 capsules in HDPE bottles with a childproof closure.

Marketing Authorisation Holder

EUSA Pharma (Netherlands) BV

Beech avenue 54,

1119PW Schiphol-Rijk

The Netherlands

Manufacturer

ALMAC PHARMA SERVICES (IRELAND) LIMITED

Finnabair Industrial Estate

Dundalk

Co. Louth

A91 P9KD

Ireland

Muhammad Nadeem

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