PRODUCTS
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DRUGS REFERENCED

 


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Blincyto (Blinatumomab)

Blinatumomab injection is used to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) after other medicines did not work well. Leukemia is a type of cancer where the body makes abnormal white blood cells.


Patent blue V

In medicine, Patent Blue V is used in lymphangiography and sentinel node biopsy as a dye to color lymph vessels.[1] [clarification needed] It is also used in dental disclosing tablets as a stain to show dental plaque on teeth.


Methotrexate

Methotrexate Pfizer (methotrexat) The treatment of neoplastic disease. The treatment of severe cases of uncontrolled psoriasis, unresponsive to conventional therapy. The treatment of adults with severe, active, classical or definite rheumatoid arthritis who are unresponsive or intolerant to conventional therapy.


Toctino (Alitretinoinum)

Toctino is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx.


Lynparza (Olaparibum)

Is indicated as montherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.


ALKERAN

ALKERAN (melphalan), also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent which is active against selective human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine.


Lentocilin

Lentocilin (benzilpenicillina benzatinica 1 200 000 UI/4ml + cloridrato de lidocaine 1.5%)
This medication is used to treat a wide variety of bacterial infections. It is also used to prevent infection of the heart (bacterial endocarditis) in patients with certain heart diseases who are having surgery. This medication is known as a natural penicillin antibiotic. It works by stopping the growth of bacteria.


OPDIVO® 

OPDIVO® (nivolumab) is a medicine that may treat your melanoma or lung cancer by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.


LENVIMA™ 

LENVIMA™ (lenvatinib) is a prescription medicine used to treat people with differentiated thyroid cancer (DTC, a type of thyroid cancer) that can no longer be treated with radioactive iodine and is progressing.


Xadago® (safinamide) 

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have unequivocally established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect also in the long term (over 2 years). Results from long-term (24 months) double-blind controlled studies suggest that safinamide shows significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This positive effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is well tolerated with a favourable side-effect profile and is easy to use: once-daily dose, no need of LD adjustment, no major drug–drug interactions, no diet restrictions due to its high MAO-B/MAO-A selectivity.


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HARVONI

HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. 28  tablets, for oral use (ledipasvir and sofosbuvir).


ONCASPAR

ONCASPAR (pegaspargase) is a formulation of L-asparaginase, the enzyme that depletes the amino acid asparagine. L-asparaginase is an important component in the treatment of acute lymphoblastic leukemia (ALL). ONCASPAR allows patients to gain the full benefits of asparaginase therapy with enhanced patient convenience over native L-asparaginase (nonpegylated form). ONCASPAR can be administered through intramuscular (IM) injection or intravenous (IV) infusion. ONCASPAR is indicated as a component of a multiagent chemotherapeutic regimen for the first–line treatment of patients with acute lymphoblastic leukemia and for the treatment of patients with acute lymphoblastic leukemia and hypersensitivity to native forms of L-asparaginase.
 


ATRIANCE

ATRIANCE (nelarabine) is a solution for infusion. ATRIANCE is used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when patients have failed to respond to, or have stopped responding to, at least two types of chemotherapy.


IMBRUVICA

IMBRUVIA (ibrutinib) is an antineoplastic agent which inhibits Bruton’s tyrosine kinase, a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). IMBRUVIA is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The benefits in CLL of IMBRUVIA are in terms of improved progression free survival (PFS) as shown in a randomised controlled trial against ofatumumab. 


VOLIBRIS

VOLIBRIS (ambrisentan) is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Volibris is used in patients with class II or III disease. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Volibris has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease. Volibris is available as tablets (5 and 10 mg).


ADCETRIS

ADCETRIS (brentuximab vedotin) is the first and only targeted CD30 antibody-drug conjugate (ADC) being evaluated in a variety of CD30-expressing malignancies including Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The ADC utilizes Seattle Genetics’ proprietary technology, which employs a linker system designed to be stable in the bloodstream but to release monomethyl auristatin E (MMAE) upon internalization into CD30-expressing tumor cells.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30-positive HL: (1) following autologous stem cell transplant (ASCT), or (2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.


Iclusig

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, a common mutation which has been associated with resistance to other approved TKIs.


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Stivarga

Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate. Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net salesof Stivarga in oncology.


XTANDI

XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration - resistant prostate cancer (mCRPC) who have previously received docetaxel. The efficacy and safety of XTANDI were assessed in a randomized, placebo-controlled, multicenter phase 3 clinical trial. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either XTANDI orally at a dose of 160 mg once daily or placebo. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. The primary endpoint of the trial was overall survival.


VOTRIENT

VOTRIENT (pazopanib) was first approved by the US Food and Drug Administration for the treatment of patients with advanced renal cell carcinoma (aRCC) in October 2009. Pazopanib received conditional marketing authorisation in the EU in June 2010 for the treatment of patients with aRCC. The CHMP recommended the conversion of the conditional marketing authorisation to a full marketing authorisation in March 2013. Pazopanib is now approved in more than 80 countries as a treatment for patients with aRCC. The therapeutic indication for pazopanib has been expanded to include treatment of patients with advanced Soft Tissue Sarcoma (aSTS), gaining US approval in April 2012 and EU approval in August 2012. Pazopanib is currently approved in more than 50 countries as a treatment for aSTS.


Kyprolis

Kyprolis is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.


XALKORI

XALKORI is a first-in-class medicine that has received conditional marketing authorization in Europe. XALKORI was first approved in the U.S. in August 2011 for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by a Food and Drug Administration (FDA)-approved test. This indication is based on response rate. There are no data available demonstrating improvements in patient-reported outcomes or survival with XALKORI. XALKORI also has received approval in a number of other countries, including Switzerland, Canada, South Korea and Japan. Additional applications are under regulatory review in several countries worldwide.


TAFINLAR

GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy.  Dabrafenib is not approved or licensed anywhere in the world for use in this treatment setting.


ZYTIGA

Since its approval in 2011, ZYTIGA has been approved in more than 60 countries worldwide, many thousands of men have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings. ZYTIGA is the only approved therapy that inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex present at three sources: the testes, adrenals and the tumour itself. The U.S. Food and Drug Administration also recently approved an expanded indication.


Sovaldi

Sovaldi in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. Additionally, Sovaldi should be used in combination with ribavirin for treatment of CHC patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation to prevent post-transplant HCV infection. Treatment regimen, duration and response to Sovaldi are dependent on viral genotype and patient population, and associated baseline factors.


Zelboraf

Zelboraf is an oral, small molecule, kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Zelboraf is not recommended for use in melanoma patients who lack the BRAF V600E mutation. Zelboraf is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group.

Roche and Genentech are conducting a broad development program with Zelboraf that includes testing combinations with other medicines (both approved and investigational, from Roche/Genentech and other companies), as well as studies in other tumor types. While Roche seeks approval of Zelboraf outside of the United States, Zelboraf is available to eligible patients with BRAF V600 mutation-positive metastatic melanoma through a global EAP.
 


Kadcyla

Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer. Like Herceptin, Kadcyla binds to HER2-positive cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once Kadcyla is taken up by those cells, it is designed to destroy them by releasing the DM1 inside the cells. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.



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