Home
My Account
About Us
Forum
Contact us
الواجهة العربية
epharmaweb.com
Medical News Medical News
Aricles Articles
Events Events
Guidelines Guidelines
Videos Library Videos Library
Diseases Diseases
Follow us : facebook twitter Digg Linkedin Boxiz
Newsletter

Please select the categories you are intersted in:
News Articles Guidelines Events Videos Journals' abstracts

Latest Subscribers
Advanced Search »



Inductos

Main

You must sign in to use this servcie


Feedback - Please use the form below to send your query or comment

You must sign in to use this servcie

Username:
Password:

Info

Indications:

indicated for single-level (L4– S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition. Also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients • Skeletal immaturity • Any active malignancy or patient undergoing treatment for a malignancy • An active infection at the operative site • Persistent compartment syndrome or neurovascular residua of compartment syndrome • Pathological fractures such as those observed in (but not limited to) Paget’s disease or in metastatic bone

Adverse reactions:

Over 1490 patients have been evaluated in clinical studies, of which more than 955 received this medicine treatment. In the long bone fracture studies, over 418 patients received this medicine. In the anterior lumber spine fusion studies, over 288 patients received this medicine. There have been post-marketing reports of localised oedema in patients undergoing cervical spine surgery associated with the use of this medicine. The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise . There have been post-marketing reports of formation of fluid collections (pseudocysts, localised oedema, implant site effusion), sometimes encapsulated, in some cases resulting in nerve compression and pain in patients undergoing spine surgery with this medicine . Nerve compression associated with ectopic bone formation has been reported in patients undergoing spine surgery with this medicine. Placement of this medicine can cause initial resorption of trabecular bone . Undesirable effects specific to use in anterior lumbar spine fusion The undesirable effects observed in anterior lumbar spine fusion patients were generally representative of the morbidity associated with spine fusion using autogenous bone graft taken from the iliac crest. Very common (1/10) undesirable effects: accidental injury, neuralgia, back pain and bone disorder, were similar in both control and this medicine treatment groups. Undesirable effects specific to use in acute tibia fractures The undesirable effects observed in long bone fracture patients were generally representative of the morbidity associated with either orthopaedic trauma or the surgical procedure. Localised infection specific to the fractured limb occurred in>1/10 patients in a clinical study in which the intramedullary canal was reamed to cortical chatter. An increased rate of infection was observed in the this medicine-treated group versus the standard of care control group (19% versus 9%, respectively) For use with unreamed nails, estimated rates of infection were similar between treatment groups in a study (21% versus 23% respectively). Common (1/100 to <1/10 ) undesirable effects were observed with equal incidence in control and this medicine treatment groups, with the following four exceptions which were observed significantly more frequently in the this medicine treatment group than in the control group: • blood amylase increased (without overt signs of pancreatitis in this medicine treated patients), • tachycardia, • hypomagnesemia, • headache.

Interactions:

No interaction studies have been performed. As dibotermin alfa is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions. Information from clinical studies in acute tibia fractures, indicated that the use of this medicine in patients receiving glucocorticoids was not associated with any apparent adverse effect. In preclinical studies, concurrent administration of glucocorticoids depressed bone repair (measured as a % change from control), but the effects of this medicine were not altered. In acute tibia fracture clinical trials, more this medicine patients receiving concomitant NSAIDs for 14 consecutive days experienced mild or moderate adverse events related to wound healing (e.g. wound drainage) than this medicine patients not taking NSAIDs. Although patient outcome was not affected, an interaction between NSAIDs and this medicine cannot be excluded.

Warnings:

Failure to follow the product preparation instructions for this medicine may compromise its safety and effectiveness. Care and caution should be used to prevent overfilling of the construct and/or intervertebral space. Localised oedema associated with the use of this medicine has been reported in patients undergoing cervical spine surgery. The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise. The safety and efficacy of this medicine in cervical spine surgery have not been established and this medicine should not be used in this condition. Formation of fluid collections (pseudocysts, localised oedema, implant site effusion), sometimes encapsulated, in some cases resulting in nerve compression and pain has been reported in patients undergoing spine surgery associated with the use of this medicine . Many of these reports have occurred when this medicine was used in unapproved approaches/devices or in a manner inconsistent with the instructions for use. Clinical intervention (aspiration and/or surgical removal) may be required if symptoms persist (see section 4.8). There are no data on the efficacy and safety of the product in concomitant use with bone graft. In the absence of any experience, the repeated use of the medicinal product is not recommended. Nerve compression associated with ectopic bone formation and this medicine use has been reported. Additional surgical intervention may be required. this medicine can cause initial resorption of surrounding trabecular bone. Therefore, in the absence of clinical data, the product should not be used for direct applications to trabecular bone when transient bone resorption may create a risk of bone fragility. When this medicine was used with the LT-CAGE device (section 4.2) in clinical trials for anterior lumbar spine fusion, the frequency and severity of resorption of bone as evidenced by radiolucencies and/or device migration was similar to that observed for patients treated with autogenous bone graft. Use of this medicine may cause heterotopic ossification in the surrounding tissues, which can result in complications. Exuberant bone formation at the site of implantation and ectopic bone formation have been observed. The safety and efficacy of the use of this medicine in patients with known autoimmune disease have not been established. These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sj?gren’s syndrome and dermatomyositis/polymyositis. The safety and efficacy of this medicine have not been demonstrated in patients with metabolic bone diseases. No studies have been performed in patients with hepatic or renal impairment. Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients. Anti-dibotermin alfa antibodies: In anterior lumbar spine fusion studies, 0.7% of patients receiving this medicine developed antibodies vs 0.8% of patients receiving autogenous bone graft. In acute tibia fracture studies, 4.4% of patients receiving this medicine developed antibodies vs 0.6% in the control group. Anti-bovine Type I collagen antibodies: In anterior lumbar spine fusion studies, 19% of patients receiving this medicine developed antibodies to bovine Type I collagen vs. 13% of patients receiving autogenous bone graft. In acute tibia fracture studies,15.7% of patients receiving this medicine developed antibodies to bovine Type I collagen vs. 11.8% of control patients. In either of the 2 indications, no patients who tested positive for anti-bovine Type I collagen antibodies developed antibodies to human Type I collagen. Although no clear association with clinical outcome or undesirable effects could be observed in clinical studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded. Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3). The possibility of an immune response to the product should be evaluated in cases where an undesirable effect with immunological background is suspected. Special warnings and precautions for use specific to anterior lumbar spine fusion The safety and efficacy of this medicine have not been established in the following conditions: • used with spinal implants other than the LT-CAGE device • implanted at locations other than L4 –S1 in the lower lumbar spine • used in surgical techniques other than anterior open or anterior laparoscopic approaches When degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages and dibotermin alfa, posterior bone formation was observed in some instances. Special warnings and precautions for use specific to acute tibia fractures this medicine is intended for use in patients with the following: • adequate fracture reduction and stabilization to ensure mechanical stability • adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation) • adequate hemostasis (providing a relatively dry implantation site) • absence of large segmental defect repair of long bones, in which significant soft tissue compression can occur The implant may only be administered to the fracture site under adequate vision and with utmost care . Efficacy information in tibia fracture is available only from controlled clinical trials in which open tibial fractures were treated using intramedullary nail fixation. In a clinical study in which the intramedullary canal was reamed to cortical chatter, an increased rate of infection was observed in the this medicine-treated group versus the standard of care control group. The use of this medicine with reamed nails in open tibial fracture repair is not recommended. this medicine does not provide mechanical stability and should not be used to fill space in the presence of compressive forces. Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection. pregnancy: Pregnancy There are no adequate data from the use of dibotermin alfa in pregnant women. Studies in animals have shown reproductive toxicity . The potential risk for humans is unknown. Animal studies have been conducted that cannot rule out effects of anti-dibotermin alfa antibodies on embryo-foetal development).Due to the unknown risks to the fetus associated with the potential development of neutralising antibodies to dibotermin alfa,this medicine should not be used during pregnancy unless clearly necessary . Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment. Lactation It is unknown whether dibotermin alfa is excreted in human breast milk. The excretion of dibotermin alfa has not been studied in animals. Lactation is not recommended during treatment with this medicine.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

You must sign in to use this servcie

Technical Description

You must sign in to use this servcie






Forgot your password


sign up

Consultants Corner

Yaser Habrawi , F.R.C.S.Ed

Yaser Habrawi , F.R.C.S.Ed Consultant Ophthalmologist

Dr. Talal Sabouni

Dr. Talal Sabouni UROLOGY AND KIDNEY TRANSPLANT

Dr . Dirar Abboud

Dr . Dirar Abboud Hepatologist – Gastroenterologist

Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician

Dr. Hani Najjar

Dr. Hani Najjar Pediatrics, Neurology

Dr. Faisal Dibsi

Dr. Faisal Dibsi Specialist of Otolaryngology - Head and Neck Surgery

Samir Moussa M.D.

Samir Moussa M.D. ENT Specialist

Dr. Tahsin Martini

Dr. Tahsin Martini Degree status: M.D. in Ophthalmology
Poll

Which of the following you are mostly interested in?

Cancer Research
Mental Health
Heart Disease & Diabetes
Sexual Health
Obesity and Healthy Diets
Mother & Child Health

Disclaimer : This site does not endorse or recommend any medical treatment, pharmaceuticals or brand names. More Details