Varuby - patient leaflet, side effects, dosage

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Manufacturing Packaging Farmaca (MPF) B.V.

Appelhof 13

NL-8465 RX Oudehaske

Netherlands

Manufacturing Packaging Farmaca (MPF) B.V.

Neptunus 12

NL-8448 CN Heerenveen

Netherlands

TESARO Bio Netherlands B.V.

Joop Geesinkweg 901

1114 AB Amsterdam-Duivendrecht Netherlands

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

• B. CONDITIONS OR RESTRICTIONS REGARDIN

  Y AND USE

  
  

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are

set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

ITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND ECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

TESARO Bio Netherlands B.V.

Joop Geesinkweg 901

18. Unique IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Varuby 90 mg tablets Rolapitant

Package leaflet: Information for the patient

Varuby 90 mg film-coated tablets

Rolapitant

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, or pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Varuby is and what it is used for

• 2. What you need to know before you take Varuby

• 3. How to take Varuby

• 4. Possible side effects

• 5. How to store Varuby

• 6. Contents of the pack and other information

1. What Varuby is and what it is used for

What Varuby is

Varuby contains the active substance rolapitant.

What Varuby is used for

Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy.

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How Varuby works

Chemotherapy can cause the body to release “substance P.”

Substance P attaches to nerve cells in the brain’s vomiting centre and makes you feel sick or be sick. Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting.

2. What you need to know before you take Varuby

Do not take Varuby:

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

• – if you take an herbal medicine called St John’s wort (Hypericum performatum) , used to treat depression and difficulty sleeping (see section 2 under ‘Other medicines and Varuby’).

If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if:

you have severe liver or kidney problems

you need to take certain medicines which may reduce the effectiveness of Varuby, such as:

• – rifampicin, to treat tuberculosis and other infections

• – carbamazepine, to treat epilepsy and nerve pain

• – phenobarbital, to treat epilepsy

• – enzalutamide, to treat

• – phenytoin, to treat epilepsy

• – efavirenz, to treat human immunodeficiency virus

• – rifabutin, to treat tuberculosis and other infections

• – other medicines that contain an NK1 antagonist, such as aprepitant and a combination of netupitant and palonosetron hydrochloride (for the prevention of nausea and vomiting associated with cancer chemotherapy) (see section 2 under ‘Other medicines and Varu

  
  

Children and adolescents

Varuby should not be taken by children and adolescents under 18 years because it has not been studied in this group.

Other medicines and Varuby medicines. Varuby may affect how some other medicines work. These include:

• – propafenone (used to treat irregular or abnormal heart beat)

• – tamoxifen (used to treat breast cancer)

• – metoprolol (used to treat high blood pressure and heart conditions)

• – thioridazine (used to treat psychiatric conditions like schizophrenia)

• – pimozide (used to treat psychiatric conditions like schizophrenia)

• – morphine (used to treat moderate to severe pain)

• – methotrexate (used to treat cancer, psoriasis, and rheumatoid arthritis)

• – irinotecan (used to treat cancer)

  
  

• – topotecan (used to treat cancer)

• – mitoxantrone (used to treat cancer

• – sulfasalazine (used to treat bowel diseas rheumatoid arthritis)

• – doxorubicin (used in cancer chemotherapy)

bendamustine (used in the treatment of leukaemia)

digoxin (used to treat heart conditions)

dabigatran (used to prevent blood clots)

colchicine (used to treat gout)

medicines called ‘statins,’ such as atorvastatin, fluvastatin, rosuvastatin and simvastatin, that are

used in the treatment of high levels of fats (such as cholesterol) in the blood

bosentan (used to treat high blood pressure in the pulmonary artery)

fexofenadine (used to treat allergy symptoms)

Pregnancy and breast-feeding

There is no information on the effects of this medicine if taken during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

It is not known whether Varuby is present in milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

Varuby has minor influence on your ability to drive and use machines. You may feel dizzy or tired after taking this medicine. If this happens, do not drive or use any tools or machines.

Varuby contains lactose

Each dose (two tablets) contains 230 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Varuby

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

• – The recommended dose is 180 mg (two 90 mg tablets). Swallow the tablets whole, with some water.

• – Take the tablets within 2 hours before you start your chemotherapy cycle.

• – You can take Varuby with or without food.

Taking Varuby before chemotherapy prevents sickness and feelings of sickness. Do not take this medicine in the days after you have chemotherapy – unless you are about to have another chemotherapy cycle. Do not take Varuby more than once every two weeks.

If you take more Varuby than you should

The usual dose is two tablets. If you think you may have taken mor straight away.

If you forget to take Varuby

If you have forgotten to take your dose, tell your

If you stop taking Varuby

Varuby helps prevent feeling sick and being sick when you have chemotherapy. If you do not want to take this medicine, discuss this with your doctor.

4. Possible side effects

cist or nurse if you notice any of the following side effects:

Serious side effects:

Rare: may affect up to 1 in 1,000 people

If you have symptoms of an allergic reaction, such as sudden shortness of breath, swelling of the lips or tongue or change in taste, swelling of skin or tissue or sudden rash or fever, or faster heartbeats, tell your doctor or nurse immediately. They will provide appropriate treatment.

Other side effects:

Common: may affect up to 1 in 10 people

• – headache

• – constipation

• – feeling tired

Uncommon: may affect up to 1 in 100 people

• – sore or painful muscles

• – feeling dizzy, difficulty concentrating, lack of energy, feeling sleepy (somnolence) or trouble

sleeping (insomnia)

• – stomach problems including stomach discomfort, bloating, nausea, pain, indigestion, and diarrhoea

• – low levels of white blood cells which fight infections (shown in blood tests)

• – infection in the mouth

• – mouth sores

• – decreased appetite

• – hiccups

• – weakness

  
  

Rare: may affect up to 1 in 1,000 people

• – thrush in the mouth or skin

• – a reduction in number of platelets (shown in blood tests)

• – increased risk of bleeding

• – decrease in white blood cells that fight infections (shown in blood tests)

• – dehydration

• – low levels of magnesium in the blood (shown in blood tests)

• – feelings of worry or fear, restlessness

• – teeth grinding

• – losing your balance

• – difficulty in moving

• – passing out or the feeling of nearly passing out

• – partial loss of hearing

• – ringing in the ears

• – blurry vision

• – heart rate increased

• – stomach discomfort

• – change in bowel habit

• – dry mouth

• – acid reflux or heartburn

• – gagging or sensation of throwin

• – high blood pressure

• – hair loss

• – skin rash, similar to acne

• – dry skin

• – pain in joint

• – back pain

• – muscle weakness

muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown (a condition called rhabdomyolysis).

problems walking

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Varuby

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 blister after ‘EXP’.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Varuby contains

The active substance is rolapitant. Each tablet contains 90 mg of rolapitant.

The other ingredients are:

• – Tablet core: lactose monohydrate (see section 2 under ‘Varuby contains lactose’), pregelatinised starch, microcrystalline cellulose (E460), povidone (K-30), croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.

• – Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.

What Varuby looks like and contents of the pack

The tablets are blue, debossed with T0101 on one side and 100 on the other side.

Pack size of two tablets in a polyvinyl chloride/polychlo­rotrifluoroet­hylene/alumini­um foil twinned blister.

Marketing Authorisation Holder

TESARO Bio Netherlands B.V.

Joop Geesinkweg 901

1114 AB Amsterdam-Duivendrecht

Netherlands

Manufacturers

Manufacturing Packaging Farmaca (MPF) B.V.

Appelhof 13

8465 RX Oudehaske

Netherlands

Manufacturing Packaging Farmaca (MPF) B.V.

Neptunus 12

8448 CN Heerenveen

Netherlands

TES aRo Bio Netherlands B.V.

Joop Geesinkweg 901

1114 AB Amsterdam-Duivendrecht

Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien

TESARO Bio Netherlands B.V.

+32 240 12501

Lietuva

TESARO Bio Netherlands B.V.

+44 330 3328100

Efc^rapufl

TESARO Bio Netherlands B.V.

'Ü +44 330 3328100

Česká republika

TESARO Bio Netherlands B.V. £+44 330 3328100

Danmark

TESARO Bio Netherlands B.V.

+45 787 74077

Deutschland

TESARO Bio GERMANY GmbH

+49 308 8789661

Eesti

TESARO Bio Netherlands B.V.

u +44 330 3328100

EXXáSa

TESARO Bio Netherlands B.V.

+44 330 3328100

España

TESARO Bio Spain S.L.U u +34 911 147439

Luxembourg/Lu­xemburg

TESARO Bio Netherlands B.V.

2 +352 278 62096

Magyarország

TESARO Bio Netherlands B.V. u +44 330 3328100

Malta

TESARO Bio Netherlands B.V.

+44 330 3328100

Nederland

TESARO Bio Netherlands B.V. +31 207 091042

Norge

TESARO Bio Netherlands £ +47 219 39680

Osterreich

TESARO Bio Netherlands B.V.

+43 192 86 528

Polska

TESARO Bio Netherlands B.V.

+ 44 330 3328100

France

TESARO Bio France SAS

Ü' +33 176 728915

Hrvatska

TESARO Bio Netherlands B.V. u +44 330 3328100

Ireland

TESARO Bio Netherlands B.V.

+

Ísland

TESARO Bio

M +4

Romania

TESARO Bio Netherlands B.V. 'Ü +44 330 3328100

Slovenija

TESARO Bio Netherlands B.V.

+44 330 3328100

Slovenská republika

TESARO Bio Netherlands B.V. 2+44 330 3328100

Suomi/Finland

TESARO Bio Netherlands B.V.

2 +358 974 790114

Kúnpog

TESARO Bio Netherlands B.V.

+44 330 3328100

Latvija

TESARO Bio Netherlands B.V.

+44 330 3328100

United Kingdom

TESARO Bio Netherlands B.V.

+44 330 3328100

This leaflet was last revised in < {MM/YYYY }>.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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