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Lartruvo (olaratumab) – Package leaflet - L01XC27

Updated on site: 08-Oct-2017

Medication nameLartruvo
ATC CodeL01XC27
Substanceolaratumab
ManufacturerEli Lilly Nederland B.V.

Package leaflet: Information for the user

Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab

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 are given 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.

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

What is in this leaflet

1.What Lartruvo is and what it is used for

2.What you need to know before you are given Lartruvo

3.How you are given Lartruvo

4.Possible side effects

5.How to store Lartruvo

6.Contents of the pack and other information

1.What Lartruvo is and what it is used for

Lartruvo contains the active substance olaratumab, which belongs to a group of medicines called monoclonal antibodies.

Olaratumab recognises and attaches specifically to a protein known as platelet-derived growth factor receptor-α (PDGFR-α). PDGFR-α is found in large amounts on some cancer cells where it stimulates the cells to grow and divide. When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival.

Lartruvo is used in combination with another anti-cancer medicine called doxorubicin for the treatment of adults with advanced soft tissue sarcoma who have not been previously treated with doxorubicin. Soft tissue sarcoma is a cancer that starts in the soft tissues, such as the muscles, fat, cartilage and blood vessels.

2. What you need to know before you are given Lartruvo

You must not be given Lartruvo

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

Warnings and precautions

You should tell your doctor about any of the following:

-if you are receiving any treatment for heart disease or liver disease

Talk to your doctor or nurse immediately if the following applies to you (or you are not sure):

Infusion-related reaction

Infusion-related reactions may occur during treatment with Lartruvo. Such reactions may be allergic. Symptoms may include back pain, chest pain and/or tightness, chills, fever, flushing, difficulty in

breathing and wheezing. In severe cases, you may experience very low blood pressure, feel faint, and experience breathing distress caused by narrowing of the airways, which could be life-threatening. Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusion- related reactions. Your doctor or nurse will check for side effects during and after your infusion. If you have a severe infusion-related reaction, your doctor may recommend reducing the dose of Lartruvo or stop your treatment with Lartruvo. See section 4 for more details about infusion-related reactions which may occur during or after the infusion.

Bleeding

Lartruvo and doxorubicin may decrease your platelet count. Platelets help your blood to clot and a low platelet count may increase the risk of bleeding. If you experience significant bleeding, symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools. Your doctor will check your platelet count prior to treatment with Lartruvo.

Reduction in the number of white blood cells

Lartruvo and doxorubicin may decrease the number of white blood cells (including neutrophils). White blood cells are important for fighting infection. A low white blood cell count may increase your risk for infection. Your doctor will check your white blood cell counts prior to treatment with Lartruvo.

Children and adolescents

Lartruvo 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.

Other medicines and Lartruvo

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

Pregnancy and breast-feeding

Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Lartruvo as this medicine may harm your unborn child. Talk to your doctor about the best contraception for you.

It is not known whether olaratumab gets into breast milk and if the breast-fed infant is at risk of harm. Ask your doctor if you can breast-feed during or after treatment with Lartruvo.

Driving and using machines

It is not known if Lartruvo will affect your ability to drive. If you get any symptoms that affect your ability to concentrate and react, such as tiredness, do not drive or use machines until the effect goes away.

Lartruvo contains sodium

This medicine contains 22 mg sodium in each 19 mL vial and 57 mg sodium in each 50 mL vial. This should be taken into consideration if you are on a controlled sodium diet.

3.How you are given Lartruvo

A doctor experienced in the use of anti-cancer medicines will supervise your Lartruvo therapy.

Premedication

You will be given medicines to reduce the risk of an infusion-related reaction before you receive Lartruvo.

Dose and administration

The recommended dose of Lartruvo is 15 mg per kilogram of your body weight on days 1 and 8 of each 3-week cycle. Lartruvo is given in combination with the medicine doxorubicin for up to 8 cycles and then it is given on its own. The number of infusions that you receive will depend on how well and for how long treatment with Lartruvo works and how well you feel. Your doctor will discuss this with you.

This medicine is given as an infusion into a vein via a drip. The drip lasts about 60 minutes.

Detailed instructions for your doctor or your nurse on how to prepare Lartruvo infusion are included at the end of this package leaflet (see ‘Handling instructions’).

Dose adjustments

During each infusion, your doctor or nurse will check for side effects. Your doctor may also give you a smaller dose or delay your dose of Lartruvo if you get serious side effects including a lowering of your white blood cell counts. If you have an infusion-related reaction during treatment, your doctor or nurse may slow down or stop your Lartruvo infusion.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

The following side effects have been reported:

Infusion reactions

Lartruvo has been associated with infusion reactions (see section 2 “Warnings and precautions”). Tell your doctor or nurse immediately if you feel unwell during infusion. Below is a list of some typical symptoms associated with infusion reactions:

Feeling faint

Fever

Chills

Flushing

Shortness of breath

Other symptoms may occur as well (see section 2 “Warnings and precautions”). Your doctor may consider slowing the Lartruvo infusion or interrupting it to manage these symptoms.

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

nausea

pain in your muscles, joints or bones (musculoskeletal pain)

low white blood cell counts (including neutrophils and lymphocytes which may increase the risk of infection)

pain or sores in your mouth or throat (mucositis)

vomiting

diarrhoea

headache

infusion-related reactions

Reporting of side effects

If you get any side effects, talk to your doctor. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Lartruvo

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 outer carton and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze or shake the vial.

Keep the vial in the outer carton to protect from light.

Infusion solution: After dilution and preparation, the medicine must be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC and up to an additional 8 hours at room temperature (below 25 ºC). Do not freeze or shake the infusion solution. Do not administer the solution if you notice any particulate matter or discoloration.

This medicine is for single use only.

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Lartruvo contains

-The active substance is olaratumab. Each millilitre of the concentrate for solution for infusion contains 10 mg of olaratumab.

Each 19 mL vial contains 190 mg of olaratumab. Each 50 mL vial contains 500 mg of olaratumab.

-The other ingredients are mannitol, glycine, L-histidine monohydrochloride monohydrate, L-histidine, sodium chloride (see section 2 “Lartruvo contains sodium”), polysorbate 20 and water for injections.

What Lartruvo looks like and contents of the pack

Lartruvo concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid supplied in a glass vial with an elastomeric stopper.

It is available in packs of:

-1 vial of 19 mL

-2 vials of 19 mL

-1 vial of 50 mL

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V.

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands.

Manufacturer

Lilly S.A.

Avda de la Industria, 30 28108 Alcobendas Madrid

Spain

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

België/Belgique/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 60 00

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6 817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges.m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France SAS

Lilly Portugal Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0)1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

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

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

Handling instructions Lartruvo 10 mg/mL

concentrate for solution for infusion olaratumab

The following information is intended for healthcare professionals only

Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.

Each vial is intended for single use only. Inspect the contents of the vials for particulate matter and discolouration. The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution. If particulate matter or discolouration is identified, the vial must be discarded.

Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab; calculate the dose and volume of olaratumab needed to prepare the infusion solution. Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.

To administer using pre-filled intravenous infusion containers

Based on the calculated volume of olaratumab, aseptically remove the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection from the prefilled 250 mL intravenous container and transfer the olaratumab medicine into the container to bring the final volume in the container back to 250 mL. Gently invert the container to mix. DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.

To administer using empty intravenous infusion containers

Aseptically transfer the calculated volume of olaratumab into an empty intravenous infusion container. Add a sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to make the total volume 250 mL. Gently invert the container to mix. DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.

Administer via an infusion pump. A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9 %) solution for injection at the end of the infusion.

Parenteral medicines should be inspected visually for particulate matter prior to administration. If particulate matter is identified, discard the infusion solution.

Discard any unused portion of olaratumab left in a vial, as the product contains no antimicrobial preservatives.

Any unused medicines or waste material should be disposed of in accordance with local requirements.

Annex IV

Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency

Conclusions presented by the European Medicines Agency on:

Conditional marketing authorisation

The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.

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