Thursday, October 27, 2016

Caelyx 2mg / ml concentrate for solution for infusion





1. Name Of The Medicinal Product



Caelyx 2 mg/ml concentrate for solution for infusion


2. Qualitative And Quantitative Composition



One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation.



Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG). This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Concentrate for solution for infusion



The suspension is sterile, translucent and red.



4. Clinical Particulars



4.1 Therapeutic Indications



Caelyx is indicated:



- As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.



- For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.



- In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.



- For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.



Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).



4.2 Posology And Method Of Administration



Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.



Caelyx exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin hydrochloride.



Breast cancer/Ovarian cancer:



Caelyx is administered intravenously at a dose of 50 mg/m2 once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.



Multiple Myeloma: Caelyx is administered at 30 mg/m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion. The bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8, and 11 every 3 weeks. The dose should be repeated as long as patients respond satisfactorily and tolerate treatment. Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary. Doses of bortezomib should be at least 72 hours apart.



For doses < 90 mg: dilute Caelyx in 250 ml 5 % (50 mg/ml) glucose solution for infusion.



For doses



To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.



In those patients who experience an infusion reaction, the method of infusion should be modified as follows:



5 % of the total dose should be infused slowly over the first 15 minutes. If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes. If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes.



AIDS-related KS:



Caelyx is administered intravenously at 20 mg/m2 every two-to-three weeks. Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out. Treatment of patients for two-to-three months is recommended to achieve a therapeutic response. Continue treatment as needed to maintain a therapeutic response.



The dose of Caelyx is diluted in 250 ml 5 % (50 mg/ml) glucose solution for infusion and administered by intravenous infusion over 30 minutes.



For all patients:



If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.



Do not administer Caelyx as a bolus injection or undiluted solution. It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5 % (50 mg/ml) glucose to achieve further dilution and minimise the risk of thrombosis and extravasation. The infusion may be given through a peripheral vein. Do not use with in-line filters. Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).



To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed. Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below. The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).



The tables for PPE (Table 1) and stomatitis (Table 2) provide the schedule followed for dose modification in clinical trials in the treatment of breast or ovarian cancer (modification of the recommended 4 week treatment cycle): if these toxicities occur in patients with AIDS related KS, the recommended 2 to 3 week treatment cycle can be modified in a similar manner.



The table for haematological toxicity (Table 3) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only. Dose modification in patients with AIDS-KS is addressed in 4.8.



Guidelines For Caelyx Dose Modification
































Table 1. PALMAR – PLANTAR ERYTHRODYSESTHESIA


   

 


Week After Prior Caelyx Dose


  


Toxicity Grade At Current Assessment




Week 4




Week 5




Week 6




Grade 1



(mild erythema, swelling, or desquamation not interfering with daily activities)




Redose unless patient has experienced a previous Grade 3 or 4 skin toxicity, in which case wait an additional week




Redose unless patient has experienced a previous Grade 3 or 4 skin toxicity, in which case wait an additional week




Decrease dose by 25 %; return to 4 week interval




Grade 2



(erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)




Wait an additional week




Wait an additional week




Decrease dose by 25 %; return to 4 week interval




Grade 3



(blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)




Wait an additional week




Wait an additional week




Withdraw patient




Grade 4



(diffuse or local process causing infectious complications, or a bedridden state or hospitalization)




Wait an additional week




Wait an additional week




Withdraw patient
































Table 2. STOMATITIS


   

 


Week after Prior Caelyx Dose


  


Toxicity Grade At Current Assessment




4




5




6




Grade 1



(painless ulcers, erythema, or mild soreness)




Redose unless patient has experienced a previous Grade 3 or 4 stomatitis in which case wait an additional week




Redose unless patient has experienced a previous Grade 3 or 4 stomatitis in which case wait an additional week




Decrease dose by 25 %; return to 4 week interval or withdraw patient per physician's assessment




Grade 2



(painful erythema, oedema, or ulcers, but can eat)




Wait an additional week




Wait an additional week




Decrease dose by 25 %; return to 4 week interval or withdraw patient per physician's assessment




Grade 3



(painful erythema, edema, or ulcers, but cannot eat)




Wait an additional week




Wait an additional week




Withdraw patient




Grade 4



(requires parenteral or enteral support)




Wait an additional week




Wait an additional week




Withdraw patient




























Table 3. HAEMATOLOGICAL TOXICITY (ANC OR PLATELETS) – MANAGEMENT OF PATIENTS WITH BREAST OR OVARIAN CANCER


   


GRADE




ANC




PLATELETS




MODIFICATION




Grade 1




1,500 – 1,900




75,000 – 150,000




Resume treatment with no dose reduction.




Grade 2




1,000 – < 1,500




50,000 – < 75,000




Wait until ANC




Grade 3




500 – < 1,000




25,000 – < 50,000




Wait until ANC




Grade 4




< 500




< 25,000




Wait until ANC



For multiple myeloma patients treated with Caelyx in combination with bortezomib who experience PPE or stomatitis, the Caelyx dose should be modified as described in Table 1 and 2 above respectively. Table 4, below provides the schedule followed for other dose modifications in the clinical trial in the treatment of patients with multiple myeloma receiving Caelyx and bortezomib combination therapy. For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.






















Table 4. DOSAGE ADJUSTMENTS FOR CAELYX + BORTEZOMIB COMBINATION THERAPY - PATIENTS WITH MULTIPLE MYELOMA


  


Patient Status




Caelyx




Bortezomib




Fever 3




Do not dose this cycle if before Day 4; if after Day 4, reduce next dose by 25 %.




Reduce next dose by 25 %.




On any day of medicine administration after Day 1 of each cycle:



Platelet count < 25,000/mm3



Hemoglobin < 8 g/dl



ANC < 500/mm3




Do not dose this cycle if before Day 4; if after Day 4 reduce next dose by 25 % in the following cycles if bortezomib is reduced for hematologic toxicity.*




Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25 % in following cycles.




Grade 3 or 4 non-hematologic medicine related toxicity




Do not dose until recovered to Grade < 2 and reduce dose by 25 % for all subsequent doses.




Do not dose until recovered to Grade < 2 and reduce dose by 25 % for all subsequent doses.




Neuropathic pain or peripheral neuropathy




No dosage adjustments.




See the SPC for bortezomib.



*for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib



Patients with impaired hepatic function: Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2 - 3.0 mg/dl, the first dose is reduced by 25 %. If the bilirubin is> 3.0 mg/dl, the first dose is reduced by 50 %. If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i.e., if reduced by 25 % for the first dose, increase to full dose for cycle 2; if reduced by 50 % for the first dose, increase to 75 % of full dose for cycle 2. The dosage can be increased to full dose for subsequent cycles if tolerated. Caelyx can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of the normal range. Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.



Patients with impaired renal function: As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required. Population pharmacokinetic data (in the range of creatinine clearance tested of 30 - 156 ml/min) demonstrate that Caelyx clearance is not influenced by renal function. No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.



AIDS-KS patients with splenectomy: As there is no experience with Caelyx in patients who have had splenectomy, treatment with Caelyx is not recommended.



Paediatric patients: The experience in children is limited. Caelyx is not recommended in patients below 18 years of age.



Elderly patients: Population based analysis demonstrates that age across the range tested (21 – 75 years) does not significantly alter the pharmacokinetics of Caelyx.



4.3 Contraindications



• Hypersensitivity to the active substance or to any of the excipients.



Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.



4.4 Special Warnings And Precautions For Use



Cardiac toxicity: It is recommended that all patients receiving Caelyx routinely undergo frequent ECG monitoring. Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx therapy. However, reduction of the QRS complex is considered more indicative of cardiac toxicity. If this change occurs, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, must be considered.



More specific methods for the evaluation and monitoring of cardiac functions as compared to ECG are a measurement of left ventricular ejection fraction by echocardiography or preferably by Multigated Angiography (MUGA). These methods must be applied routinely before the initiation of Caelyx therapy and repeated periodically during treatment. The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx that exceeds a lifetime cumulative anthracycline dose of 450 mg/m2.



The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy. If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.



In patients with cardiac disease requiring treatment, administer Caelyx only when the benefit outweighs the risk to the patient.



Exercise caution in patients with impaired cardiac function who receive Caelyx.



Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g. < 45 %), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.



Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.



Caution must be observed in patients who have received other anthracyclines. The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/anthraquinones or e.g. 5-fluorouracil. Cardiac toxicity also may occur at cumulative anthracycline doses lower than 450 mg/m2 in patients with prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy.



The cardiac safety profile for the dosing schedule recommended for both breast and ovarian cancer (50 mg/m2) is similar to the 20 mg/m2 profile in patients with AIDS-KS (see section 4.8).



Myelosuppression: Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow. In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m2, myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis. Moreover, in a controlled clinical trial of Caelyx vs. topotecan, the incidence of treatment related sepsis was substantially less in the Caelyx-treated ovarian cancer patients as compared to the topotecan treatment group. A similar low incidence of myelosuppression was seen in patients with metastatic breast cancer receiving Caelyx in a first-line clinical trial. In contrast to the experience in patients with breast cancer or ovarian cancer, myelosuppression appears to be the dose-limiting adverse event in patients with AIDS-KS (see section 4.8). Because of the potential for bone marrow suppression, periodic blood counts must be performed frequently during the course of Caelyx therapy, and at a minimum, prior to each dose of Caelyx.



Persistent severe myelosuppression, may result in superinfection or haemorrhage.



In controlled clinical studies in patients with AIDS-KS against a bleomycin/vincristine regimen, opportunistic infections were apparently more frequent during treatment with Caelyx. Patients and doctors must be aware of this higher incidence and take action as appropriate.



As with other DNA-damaging antineoplastic agents, secondary acute myeloid leukemias and myelodysplasias have been reported in patients having received combined treatment with doxorubicin. Therefore, any patient treated with doxorubicin should be kept under haematological supervision.



Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.



Infusion-associated reactions: Serious and sometimes life-threatening infusion reactions, which are characterised by allergic-like or anaphylactoid-like reactions, with symptoms including asthma, flushing, urticarial rash, chest pain, fever, hypertension, tachycardia, pruritus, sweating, shortness of breath, facial oedema, chills, back pain, tightness in the chest and throat and/or hypotension may occur within minutes of starting the infusion of Caelyx. Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8). Temporarily stopping the infusion usually resolves these symptoms without further therapy. However, medications to treat these symptoms (e.g., antihistamines, corticosteroids, adrenaline, and anticonvulsants), as well as emergency equipment should be available for immediate use. In most patients treatment can be resumed after all symptoms have resolved, without recurrence. Infusion reactions rarely recur after the first treatment cycle. To minimise the risk of infusion reactions, the initial dose should be administered at a rate no greater than 1 mg/minute (see section 4.2).



Diabetic patients: Please note that each vial of Caelyx contains sucrose and the dose is administered in 5 % (50 mg/ml) glucose solution for infusion.



For common adverse events which required dose modification or discontinuation see section 4.8.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies. Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride. Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies. During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted. In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride. Caution must be exercised when giving any other cytotoxic agents, especially myelotoxic agents, at the same time.



4.6 Pregnancy And Lactation



Pregnancy: Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy. Therefore, Caelyx should not be used during pregnancy unless clearly necessary.



Women of child-bearing potential must be advised to avoid pregnancy while they or their male partner are receiving Caelyx and in the six months following discontinuation of Caelyx therapy (see section 5.3).



Lactation: It is not known whether Caelyx is excreted in human milk. Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx treatment. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.



4.7 Effects On Ability To Drive And Use Machines



Caelyx has no or negligible influence on the ability to drive and use machines. However, in clinical studies to date, dizziness and somnolence were associated infrequently (< 5 %) with the administration of Caelyx. Patients who suffer from these effects must avoid driving and operating machinery.



4.8 Undesirable Effects



The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m2 every 4 weeks) was palmar-plantar erythrodysesthesia (PPE). The overall incidence of PPE reported was 44.0 % - 46.1 %. These effects were mostly mild, with severe (Grade III) cases reported in 17 % - 19.5 %. The reported incidence of life-threatening (Grade IV) cases was < 1 %. PPE infrequently resulted in permanent treatment discontinuation (3.7 % - 7.0 %). PPE is characterised by painful, macular reddening skin eruptions. In patients experiencing this event, it is generally seen after two or three cycles of treatment. Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution. Pyridoxine at a dose of 50 - 150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials. Other strategies to prevent and treat PPE, which may be initiated for 4 to 7 days after treatment with Caelyx include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting). PPE appears to be primarily related to the dose schedule and can be reduced by extending the dose interval 1 - 2 weeks (see section 4.2). However, this reaction can be severe and debilitating in some patients and may require discontinuation of treatment. Stomatitis/mucositis and nausea were also commonly reported in breast/ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS). PPE was reported in 16 % of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy. Grade 3 PPE was reported in 5 % of patients. No grade 4 PPE was reported. The most frequently reported (medicine-related treatment-emergent) adverse events in combination therapy (Caelyx + bortezomib) were nausea (40 %), diarrhoea (35 %), neutropaenia (33 %), thrombocytopaenia (29 %), vomiting (28 %), fatigue (27 %), and constipation (22 %).



Breast cancer program: 509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin (n=255) at a dose of 60 mg/m2 every 3 weeks, in a phase III clinical trial (I97-328). The following common adverse events were reported more often with doxorubicin than with Caelyx: nausea (53 % vs. 37 %; Grade III/IV 5 % vs. 3 %), vomiting (31 % vs. 19 %; Grade III/IV 4 % vs. less than 1 %), any alopecia (66 % vs. 20 %), pronounced alopecia (54 % vs.7 %), and neutropaenia (10 % vs. 4 %; Grade III/IV 8 % vs. 2 %).



Mucositis (23 % vs. 13 %; Grade III/IV 4 % vs. 2 %), and stomatitis (22 % vs. 15 %; Grade III/IV 5 % vs. 2 %) were reported more commonly with Caelyx than with doxorubicin. The average duration of the most common severe (Grade III/IV) events for both groups was 30 days or less. See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.



The incidence of life threatening (Grade IV) haematologic effects was < 1.0 % and sepsis was reported in 1 % of patients. Growth factor support or transfusion support was necessary in 5.1 % and 5.5 % of patients, respectively (see section 4.2).



Clinically significant laboratory abnormalities (Grades III and IV) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4 %, 1.6 % and < 1 % of patients respectively. No clinically significant increases in serum creatinine were reported.




















































































































































Table 5. Treatment Related Undesirable Effects Reported in Breast Cancer Clinical Trials



(50 mg/m2 every 4 weeks) (Caelyx-treated patients)



by Severity, MedDRA System Organ Class and Preferred Term



Very Common (



CIOMS III


   


AE by body system




Breast Cancer



All Severities



n=254



(




Breast Cancer Grades III/IV



n=254



(




Breast Cancer



n=404



(1-5 %)



not previously reported in clinical trials




Infections and infestations


   


Common




Pharyngitis



 


Folliculitis, fungal infection, cold sores (non-herpetic), upper respiratory tract infection




Uncommon



 


Pharyngitis



 


Blood and lymphatic system disorders


   


Common




Leukopaenia, anaemia, neutropaenia, thrombocytopaenia




Leukopaenia, anaemia




Thrombocythemia




Uncommon



 


Neutropaenia



 


Metabolism and nutrition disorders


   


Very Common




Anorexia



 

 


Common



 


Anorexia



 


Nervous system disorders


   


Common




Paresthesia




Paresthesia




Peripheral neuropathy




Uncommon




Somnolence



 

 


Eye Disorders


   


Common



 

 


Lacrimation, blurred vision




Cardiac disorders


   


Common



 

 


Ventricular arrhythmia




Respiratory, thoracic and mediastinal disorders


   


Common



 

 


Epistaxis




Gastrointestinal disorders


   


Very Common




Nausea, stomatitis, vomiting



 

 


Common




Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration




Abdominal pain, diarrhoea, nausea, stomatitis




Oral pain




Uncommon



 


Mouth ulceration, constipation, Vomiting



 


Skin and subcutaneous tissue disorders


   


Very Common




PPE*, alopecia, rash




PPE*



 


Common




Dry skin, skin discolouration, pigmentation abnormal, erythema




Rash




Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin




Uncommon



 


Pigmentation abnormal, erythema



 


Musculoskeletal and connective tissue disorders


   


Common



 

 


Leg cramps, bone pain, musculoskeletal pain




Reproductive system and breast disorders


   


Common



 

 


Breast pain




General disorders and administration site conditions


   


Very Common




Asthenia, fatigue, mucositis NOS



 

 


Common




Weakness, fever, pain




Asthenia, mucositis NOS




Oedema, leg oedema.




Uncommon



 


Fatigue, weakness, pain



 


* palmar-plantar erythrodysesthesia (Hand- foot syndrome).



Ovarian cancer program: 512 patients with ovarian cancer (a subset of 876 solid tumour patients) were treated with Caelyx at a dose of 50 mg/m2 in clinical trials. See Table 6 for undesirable effects reported in Caelyx-treated patients.








Table 6 Treatment Related Undesirable Effects Reported in Ovarian Cancer Clinical Trials



(50 mg/m2 every 4 weeks) (Caelyx-treated patients)



by Severity, MedDRA System Organ Class and Preferred Term



Very Common (



CIOMS III


   

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