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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnwesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Our belief—and the core of our strategy—is that innovative, highly
differentiated medicines that provide large clinical benefits in addressing serious diseases are medicines that will not only help patients, but also will help reduce the social and economic burden of disease in society today.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology innovator since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Drugs Disributed by Amgen Europe B.V
TNF Blocking Agent. Adalimumab 50 mg/ml.. PRE-FILLED SYRINGE: 2 ×(20 mg/0.4 mL, 40mg/0.8ml)
PRE-FILLED PEN: 2× (40mg /0.8 ml).
Dosage ajust. individ. accord. to pt. med. condit.
RA: in comb. with methotrexate-tmt. of moder.-sev., active RA in adult pts. when the response to dis.-modif. anti-rheumat.drugs includ. methotrexate has been inadequate.
The tmt. of sev., active and progres. RA in adult.not previous. treated with methotrexate, given as monother. in case of intolerance to methotrexate or when continued tmt. with methotrexate is inappropr. AMGEVITA has been shown to reduce the rate of progress. of joint damage as measured by X-ray and to improve physical funct., when given in comb. with methotrexate.
Axial spondyloarthritis Ankylosing spond. (AS): tmt. of adult. with severe active AS who have had an inadeq. response to convent. ther.
Axial spondyloarthritis without radiograph. evidence of AS: tmt. of adults with sev. axial spondyloarthritis without radiograph.evidence of AS, but with object. signs of inflamm. by radiolog. and/or lab. tests includ. MRI and serum CRP levels, who have had an inadequate response to, or are intoler, to,NSAID’s.
Psoriatic arthritis: tmt. of active and progress. psoriat. arthritis in adults when the response to previous dis.-modif. anti-rheum.drug ther. has been inadequate. Adalimumab has been shown to reduce the rate of progress. of peripher. joint damage as measured by X-ray in pts. with polyarticular symmetr. subtypes of the dis. and to improve physic. func.
Psoriasis: tmt. of moder.-sev. chron. plaque psoriasis in adult pts. who are candidates for system. ther.
Hidradenitis suppurativa (HS): tmt. of active moder.- sev. hidradenitis suppurativa (acne inversa) in adult pts. with an inadequate response to convent. system. HS ther.
Crohn’s dis. : reducing signs and sympt.and induc.and maintain. clinical remiss. in adult pts. with moder.- sev. active Crohn’s dis. who have had an inadequate response to convent. ther. AMGEVITA is indic. for reduc. signs and sympt. and induc. clinical remiss. in these pts. if they have also lost response to or are intoler. to infliximab.
Ulcerat. colit.: tmt. of moder.-sev. active ulcerat. colit. in adult pts. who have had an inadequate response to convent. ther. includ. corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intoler. to or have med. contraindicat. for such therapies.
Uveitis : tmt. of non-infect. intermed., posterior and panuveitis in adult pts. who have had an inadequate response to corticosteroids, in pts. in need of corticosteroid-sparing, or in whom corticosteroid tmt. is inappropr.
Intestinal Behcet's dis.: tmt. of intestin. Behcet’s dis. in pts. who have had an inadequate response to convention. ther.
Active tuberculosis or other sev. infect. such as sepsis, and opportunist.infec.
Moder.-sev. HF(NYHA class III/IV).
Recombinant Human Erythropoietin. Darbepoetin Alfa 10, 20, 30, 40, 50, 60, 80, 100, 150, 300, 500 mcg. PREFILL. SYRINGES (for single use only, with/out automat. needle guard): 4 x 10 μg; 20 μg; 30 μg; 40 μg; 50 μg; 60 μg; 80 μg; 100 μg, 150 μg; 1 x 300 μg, 500 μg. For I.V. and S.C. admin. Similar efficacy in I.V. and S.C. admin.
PREFILL. PEN (SureClick) (single use only): 1 x 20 μg, 40 μg, 60 μg, 80 μg, 100 μg,150 μg, 300 μg, 500 μg. S.C. admin only.
Tmt. anem. assoc. with chron. ren. fail. in adults and pediatric subjects 1 yrs of age and over. Aranesp 150, 300, 500 -also tmt. anem. in adult cancer pts. with non-myeloid malignancies receiv. chemother.
C/I: Hpersenes. Poorly control. hypertens.
Monoclonal Antibody. Blinatumomab 12.5 mcg/ml. VIAL (concentr. for sol. for infus.+ stabilizer sol. for infus.): 1×35mcg. Recommen. dly. dose is by pt. wt. Pts. greater than or equal to 45 kg receive a fixed-dose and for pts. less than 45 kg, dose is calc. using the pt’s. body surface area. (BSA).
Recommen. dose for adult pts. at least 45 kg in wt. (fixed-dose): 1st Cycle: Start. dose Days 1–7: 9 mcg/d via cont. infus.
Subseq. dose Days 8–28: 28 mcg/d via cont. infus. 2 week-tmt. free interval (Days 29-42).
2nd cycle & subseq. cycles: (Days 1–28): 28 mcg/d via cont. infus.
Pts. less than 45 kg (BSA-based dose):
Days 1-7: 5 mcg/m²/day via cont. infus. (do not exceed 9 mcg/day).
Days 8-28: 15 mcg/m²/d via contin. infus. (do not exceed 28 mcg/d).
Subseq. Cycle Days 1-28: 15 mcg/m²/d via contin. infus. (do not exceed 28 mcg/d).
MRD posit. B-precursor ALL for Philadelphia chrom. negat.: pts. may receive 1 cycle of induct. tmt. follow. by up to 3 addit. cycles of consol. tmt. A sgle. cycle of tmt. induct. or consol. is 28 d. (4 wks.) of contin. IV infus. follow. by a 14 d. (2 wk.) tmt. -free interv. (total 42 d.). The major. of pts. who resp. to blinatumomab achieve a resp. aft. 1 cycle. Therefore, the potent. benefit and risks assoc. with contin. ther. in pts. who do not show haematolog. and/or clinic. improv. after 1 tmt. cycle should be assessed by treat. phys. See lit.
Monother. for tmt. of adlts. with CD19 posit. relapsed or refract. B prec. ac. lymphobl. leuk.(ALL). Pts. with Philadelphia chrom. posit. B-prec. ALL should have failed tmt. with at least 2 tyrosine kinase inhibitors (TKIs) and have no tmt. options.
Monother. for tmt. of adlts. with Philadelphia chrom. negat. CD19 pos. B-prec. ALL in first or sec. compl. remission with min. res. dis. (MRD) greater than or equal to 0.1%.
Monother. for tmt of ped. pts aged 1 year min. with Philadelphia chrom. neg. CD19 pos. B-precursor ALL refract. or in relapse aft. receiving at least 2 prior ther. or in relapse aft. rec. prior allogen. hematop. stem cell transplant.
Monother. for tmt. of ped. pts. aged 1 year min. with high-risk first relapsed Philadelphia chrom. neg. CD19 posit. B-prec. ALL as part of the consolid. ther.
Limit. of use:aft. fail. of 2 prev. tmts. and with no CNS involv.
C/I: Hypersens. Breastfeeding.
Monoclonal Antibody. Romosozumab 90 mg / mL 90mg/ml. PRE-FILL. SYR. (sol. for S.C. inj.):2. 210 mg admin. S.C. in the abdo., thigh or upper arm. admin. once every month.
The tmt. duration is 12 mnthly. doses.
Pts. should be adequat. supplem. with calcium & vit. D during tmt.
If the dose is missed, admin.as soon as it can be rescheduled. Thereafter, the dose can be scheduled every month from the date of the last dose.
Tmt. of severe osteoporosis in postmenop. women at high risk for fract., defined as a history of osteoporotic fract., or multiple risk fact. for fracture; or pts. who have failed or are intoler. to other available osteoporosis ther.
Hypocalcem., Pre-exist. hypocalc.
Pts. who experiences a MI or stroke during ther.
Pts. who had a MI or stroke within the preceding year.
Antineoplastic, Immunomodulator Agent. Talimogene Laherparepvec 10^6 PFU/ml, 10^8 PFU/ml. Talimogene laherparepvec, attenuate. herpes S. virus type-1 (HSV-1) derived by funct. deletion of 2 genes (ICP34.5& ICP47) and insert. of coding sequen. for human granulocyte macrophage colony-stimulat. factor (GM-CSF).
106- 1×106 (1 million) plaque form. units (PFU)/mL.
108- 1×108 (100 million) plaque form. units (PFU)/mL
VIAL (sol. for inj.): 1. Dosage must be ajust. individ.
Tmt. of adult. with unresect. melanoma that is regional. or distant. metastat. (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral dis.
C/I: Pts. with a history of hypersens. to talimogene laherparepvec.
Severely immunocompromised pts. (e.g. pts. with severe congen. or acquired cellular and/or humoral immune deficien.).
Monoclonal Antibody. Trastuzumab 150, 420 mg. VIAL (Pwdr. for concentrate for sol. for infus.): 1. Dosage must be ajust. individ accord. pt. med. cond. and indication.
Tmt. of pts. with metast. breast canc. who have tumors that overexpress HER2;
As a single agent, for the tmt. of those pts. who have received one or more chemother. regim. for their metast. dis.
In comb. with Paclitaxel or Docetaxel for the tmt. of those pts. who have not received chemother. for their metast. dis.
In comb. with an aromatase inhib. for the tmt. of postmenopaus. pt. with hormonereceptor positive metast. breast canc.
Early breast cancer (EBC) – pts. with HER2 positive early breast cancer follow. surg. and chemother. (neoadjuv./ adjuvant) either alone or in comb. with chemother. exclude. anthracyclines.
The drug should only be used in pts. whose tumors have either HER2 overexpres. or HER2 gene amplificat. as determ. by an accurate and validated assay. HER2 Metastat. gast. cancer (MGC)- in comb. with capecitabine or 5-fluorouracil and cisplatin is indic. for the tmt. of pts. with HER2-positive metast. adenocarcinoma of the stomach or gastroesophag. junction who have not received prior anti-cancer tmt. for their metastat. dis.
Trastuzumab should only be used in pts. with metastat. gast. cancer (MGC) whose tumours have HER2 overexpres. as defined by IHC 2+ and a confirmatory FISH+ result, or IHC 3+, as determ. by an accurate and validated assay.
C/I: Hypersens. Severe dyspnea at rest due to complicat. of advanced malig. or require. supplement. oxygen ther.