Lartruvo

Olaratumab therapy must be initiated and supervised by physicians experienced in oncology. 4). Posology The recommended dose of olaratumab is 15 mg/kg administered by intravenous infusion on days 1 and 8 of each 3 week cycle until disease progression or unacceptable toxicity.

Lartruvo is administered in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo monotherapy inMedicinal product no longer authorised 3 patients whose disease has not progressed. Doxorubicin is given on day 1 of each cycle following the Lartruvo infusion.

, diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30–60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients. , diphenhydramine) should be given intravenously 30–60 minutes prior to each dose of olaratumab.

For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed. For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.

g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion). Posology adjustments for olaratumab For dose adjustment recommendations related to doxorubicin, refer to the current doxorubicin prescribing information.

Infusion-related reactions (IRRs) Recommendations for the management of olaratumab IRRs are provided in table 1. b • Monitor patient for worsening of condition. • For subsequent infusions, please see premedication section. 4). 03 b Once the infusion rate has been reduced for a Grade 1 or 2 infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.

The infusion duration should not exceed 2 hours. Other non-haematology toxicities For serious Grade ≥ 3 non-haematologic toxicity deemed related to olaratumab, the dose of olaratumab should be withheld until toxicity is ≤ Grade 1 or has returned to pretreatment baseline.

For subsequent infusions, the dose should be reduced to 12 mg/kg for serious Grade 3 toxicities and to 10 mg/kg for Grade 4 toxicities. If a Grade 3 toxicity recurs despite the dose reduction, the dose should be reduced further to 10 mg/kg.

8 %). The most frequently occurring ADRs were nausea, musculoskeletal pain, neutropenia and mucositis. 6 %). Known toxicities reported for doxorubicin, observed in the combination of olaratumab and doxorubicin include fatigue, anaemia, thrombocytopenia and alopecia.

Please refer to the doxorubicin SmPC for complete descriptions of all adverse events associated with doxorubicin treatmentMedicinal product no longer authorised 7 Tabulated list of adverse reactions ADRs which were reported in patients with soft tissue sarcoma treated with olaratumab in combination with doxorubicin in the Phase 2 study are listed below in Table 2 in MedDRA body system organ class, frequency and grade of severity.

The following convention has been used for classification of frequency:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Within each frequency grouping, ADRs are presented in order of decreasing seriousness. 03) for each Grade of toxicity b Musculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity.

c Infusion-related reactions includes anaphylactic reactions/anaphylactic shock. 5 % of patients and mainly present as chills, fever or dyspnoea. 1 % of patients and mainly presented with shortness of breath, loss of consciousness and hypotension.

All severe IRRs occurred during or immediately after the first administration of olaratumab. 8 % (Grade 3) in the doxorubicin alone arm. 8 % in the doxorubicin alone arm. 5 % (Grade 3) in theMedicinal product no longer authorised 8 doxorubicin alone arm.

In the majority of patients the pain was related to the patients’ underlying cancer or metastases or pre-existing or concomitant conditions. The majority of these events occurred in the first 4 cycles. The pain can last from few days to up to 200 days.

Infusion-related reactions Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab. The majority of these reactions occurred during or following the first olaratumab infusion.

Symptoms of IRRs included flushing, shortness of breath, bronchospasm, or fever/chills, and in some cases manifested as severe hypotension, anaphylactic shock, or fatal cardiac arrest. Severe IRRs such as anaphylactic reactions can occur despite the use of premedication.

Patients should be monitored during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. 2. In patients who have experienced a previous Grade 1 or 2 IRR, premedication with diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone is recommended.

8). Neutrophil count should be checked prior to Olaratumab dosing on Day 1 and Day 8 of each cycle. Neutrophil count should be monitored during the treatment with olaratumab and doxorubicin and supportive care should be administered such as antibiotics or G-CSF as per local guidelines.

2. 8). Platelet counts should be checked prior to olaratumab dosing on Day 1 and Day 8 of each cycle. Coagulation parameters should be monitored in patients with conditions predisposing to bleeding, such as anticoagulant use. In a study of olaratumab in combination with liposomal doxorubicin, there was one case of fatal intracranial haemorrhage in a patient who had experienced a fall while on treatment.

Anthracycline pre-treated patients The risk of cardiac toxicity rises with increasing cumulative doses of anthracyclines, including doxorubicin. 1). Sodium restricted diet This medicinal product contains 22 mg sodium per each 19 mL vial and 57 mg sodium per each 50 mL vial.

To be taken into consideration by patients on a controlled sodium diet. Cardiac toxicity Doxorubicin can cause cardiotoxicity. The risk of toxicity rises with increasing cumulative doses and is higher in individuals with a history of cardiomyopathy, mediastinal irradiation or pre-existing cardiac disease.

1.