Carfilzomib is indicated for the treatment of adult patients with relapsed or refractory
multiple myeloma who have received to three lines of therapy in combination with:
- Lenalidomide and dexamethasone; or
- Dexamethasone; or
- Daratumumab and dexamethasone; or
- Daratumumab and hyaluronidase-fihj and dexamethasone; or
- Isatuximab and dexamethasone.
Carfilzomib BOS is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received or more lines of therapy.
Carfilzomib is indicated for the treatment of adult patients with relapsed or refractory
multiple myeloma who have received to three lines of therapy in combination with:
- Lenalidomide and dexamethasone; or
- Dexamethasone; or
- Daratumumab and dexamethasone; or
- Daratumumab and hyaluronidase-fihj and dexamethasone; or
- Isatuximab and dexamethasone.
Carfilzomib is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received or more lines of therapy.
Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary
haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease
Itraconazole Oral Solution is indicated:
- for the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients.
- as prophylaxis of deep fungal infections anticipated to be susceptible to itraconazole, when standard therapy is considered inappropriate, in patients with haematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 cells/μL). At present, there are insufficient clinical efficacy data in the prevention of aspergillosis.
Consideration should be given to national and/or local guidance regarding the appropriate use of antifungal agents.
Risek Plus capsules are indicated in adults for the:
- short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
- short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
- treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
- short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
- The efficacy of Omeprazole/ Sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Risek Plus may be considered.
- maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men 18 to 64 years.
Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria:
• An intravaginal ejaculatory latency time (IELT) of less than two minutes.
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes.
• Marked personal distress or interpersonal difficulty as a consequence of PE.
• Poor control over ejaculation.
• A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Dapoxetine should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men 18 to 64 years.
Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria:
• An intravaginal ejaculatory latency time (IELT) of less than two minutes.
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes.
• Marked personal distress or interpersonal difficulty as a consequence of PE.
• Poor control over ejaculation.
• A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Dapoxetine Hydrochloride should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Metastatic Colorectal Cancer (mCRC)
• Bevacizumab in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC).
• Bevacizumab in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
• Bevacizumab in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
Recurrent Glioblastoma (GBM)
• Bevacizumab is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma (mRCC)
• Bevacizumab in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
• Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Bevacizumab in combination with carboplatin and paclitaxel, followed by Acura® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
• Bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
• Bevacizumab in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Acura® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Hepatocellular Carcinoma (HCC)
• Bevacizumab in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
