Viatrexx Derma
Viatrexx Derma Uses, Dosage, Side Effects, Food Interaction and all others data.
Basic Fibroblast Growth Factor (bFGF) is a single-chain polypeptide growth factor that plays a significant role in the process of wound healing and is a potent inducer of physiologic angiogenesis. Several different forms of the human protein exist ranging from 18-24 kDa in size due to the use of alternative start sites within the fgf-2 gene. It has a 55 percent amino acid residue identity to Fibroblast Growth Factor 1 and has potent heparin-binding activity. The growth factor is an extremely potent inducer of DNA synthesis in a variety of cell types from mesoderm and neuroectoderm lineages. It was originally named basic fibroblast growth factor based upon its chemical properties and to distinguish it from acidic fibroblast growth factor (Fibroblast Growth Factor 1). Although it is not approved for use in Canada or the USA, bFGF is currently undergoing investigation in a number of clinical trials.
Calcium gluconate is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function.
Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.
Centella asiatica is a plant/plant extract used in some OTC (over-the-counter) products. It is not an approved drug.
Hyaluronidase is a dispersion agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of an N-acetylglucosamine moiety and C4 of a glucuronic acid moiety. This temporarily decreases the viscosity of the cellular cement and promotes dispersion of injected fluids or of localized transudates or exudates, thus facilitating their absorption. Hyaluronidase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.
Mecasermin contains recombinant-DNA-engineered human insulin-like growth factor-1 (rhIGF-1). IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Mecasermin is a biosynthetic (recombinant DNA origin) form of human insulin-like growth factor 1 (IGF-1) designed to replace natural IGF-1 in pediatric patients who are deficient, promoting normalized statural growth. Growth hormones (GH) bind to growth hormone receptors (GHR) in the liver and other tissues, which stimulates the synthesis of IGF-1. In target tissues, IGF-1 activates the IGF-1 receptor, resulting in intracellular signals that stimulate growth . Although many actions of the GH are mediated through IGF-1, the precise roles of GH and IGF-1 have not been fully elucidated. Patients with severe primary IGF-1 deficiency (Primary IGFD) fail to produce adequate levels of IGF-1, due to disruption of the GH pathway used to promote IGF-1 release (possible GH pathway disruptions include mutations in the GHR, post-GHR signaling pathway, and IGF-1 gene defects).
Pork Collagen is used within MACI® (autologous cultured chondrocytes on porcine collagen membrane) as an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. It serves as an alternative repair treatment for patients with inadequate response to pre-existing surgical methods. The surgical implantation shows a tolerable safety profile and efficacy up to 4 years, but it is not indicated for patients with osteoarthritis. It has been used since 1995 as Carticel and gained biologic license in 1997. The surgical implantation was first performed in Sweden.
Sus scrofa placenta is an animal extract used in some OTC (over-the-counter) products. It is not an approved drug.
| Trade Name | Viatrexx Derma |
| Generic | Basic fibroblast growth factor + calcium gluconate + centella asiatica + pork collagen + hyaluronidase + mecasermin + bos taurus placenta + sus scrofa placenta |
| Type | Injection |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Basic Fibroblast Growth Factor is not currently approved for any FDA or Health Canada approved indications.
Calcium Gluconate is used for Antidote in severe hypermagnesaemia, Severe hyperkalaemia, Hypocalcaemic tetany, Severe acute hypocalcaemia, Hypocalcaemia and calcium deficiency states
Hyaluronidase recombinant is a tissue permeability modifier used as an adjuvant-
- In subcutaneous fluid administration for achieving hydration
- To increase the dispersion and absorption of other injected drugs
- In subcutaneous urography for improving resorption of radiopaque agents
Mecasermin is a recombinant insulin-like growth factor-1 used for the long-term treatment of growth failure in pediatric patients with primary IGF-1 deficiency or with growth hormone gene deletion due to the development of neutralizing antibodies to GH.
For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH . It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes; it is not a substitute for GH therapy.
indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.
Viatrexx Derma is also used to associated treatment for these conditions: Bone and tooth decay, Bone and tooth growth, Calcium Deficiency, Hypocalcemia, Nutritional Rickets, Osteomalacia, Osteoporosis, Otospongiosis, Postmenopausal Osteoporosis, Vitamin D Insufficiency, Vitamin D Resistant RicketsBurns first degree, Capillary fragility, Pruritus, Radiation Burn, Second Degree Burns, Skin Ulcer, Venous Insufficiency, Damaged skin, Massage, Skin CareParenteral rehydration therapy, Parenteral drug administration, Subcutaneous urographyPrimary Insulin-like Growth Factor-1 DeficiencyCartilage Damage
How Viatrexx Derma works
Calcium is essential for the functional integrity of the nervous, muscular, and skeletal systems. It plays a role in normal cardiac function, renal function, respiration, blood coagulation, and cell membrane and capillary permeability. Also, calcium helps to regulate the release and storage of neurotransmitters and hormones, the uptake and binding of amino acids, absorption of vitamin B 12, and gastrin secretion. The major fraction (99%) of calcium is in the skeletal structure primarily as hydroxyapatite, Ca 10(PO 4) 6(OH) 2; small amounts of calcium carbonate and amorphous calcium phosphates are also present. The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body's more acute needs. Therefore, on a chronic basis, normal mineralization of bone depends on adequate amounts of total body calcium.
Hyaluronidase cleaves hyaluronic acid at the glucosaminidic bond between C1 of glucosamine and C4 of glucuronic acid. Hyaluronic acid is a key component of the extracellular matrix. Injection of hyaluronidase with other fluids, drugs, or radiopaque agents improves the ability of these other compounds to permeate the extracellular space more easily.
Mecasermin supplies recombinant-DNA-origin IGF-1, which binds to the Type I IGF-1 receptor. This receptor exerts intra-cellular signaling activity in a number of processes involved in statural growth, including mitogenesis in multiple tissue types, chondrocyte growth and division along cartilage growth plates, and increases in organ growth.
Dosage
Viatrexx Derma dosage
Intravenous: Antidote in severe hypermagnesaemia, Severe hyperkalaemia:
- Adult: 10 ml of 10% calcium gluconate solution over 2 minutes, repeated every 10 minutes if needed.
- Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.
Intravenous: Hypocalcaemic tetany, Severe acute hypocalcaemia:
- Adult: 2.25 mmol by slow IV inj over 10 minutes, followed by 58-77 ml of 10% calcium gluconate solution in 0.5-1 L of 5% dextrose solution as continuous IV infusion.
- Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.
Inject 150 units Hyaluronidase recombinant prior to subcutaneous fluid administration. It will facilitate absorption of 1,000 mL or more of solution. The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion
Increasing dispersion and absorption of injected drugs: Add 50-300 units (most typically 150 U) Hyaluronidase recombinant to the injection solution.
Subcutaneous Urography: Inject 75 units Hyaluronidase recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites
Side Effects
GI irritation; soft-tissue calcification, skin sloughing or necrosis after IM/SC inj. Hypercalcaemia characterised by anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, renal calculi; chalky taste, hot flushes and peripheral vasodilation.
The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequently reported adverse reactions have been mild local injection site reactions such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
Toxicity
Infants : LDLo (Intramuscular ) : 10gm/kg ; Effects - Brain and coverings : meningeal changes Infants : TDLo ( Intramuscular ) : 143 mg/kg ; Effects - Dermatits Mouse: LD50 ( intravenous ) : 950mg/kg Mouse : LDLo (Oral ) : 10gm/kg
Data regarding overdose of hyaluronidase is not readily available. In the even of an overdose, treat patients with symptomatic and supportive measures.
Overdosage of Mecasermin leads to hypoglycemia. One case of acute overdose was treated with IV glucose. Long-term overdosage may result in signs and symptoms of acromegaly. The effects of Mecasermin in human pregnancy has not been studied, however effects on fetal development in animal studies were only seen at doses higher than the maximum recommended human dose based on body surface area. Studies on excretion of the drug in human milk, use in patients under 2 years, use in patients over 65 years, or use in patients with renal or hepatic impairment have not been performed.
Precaution
Impaired renal function; cardiac disease; hypercalcaemia-associated diseases, e.g. sarcoidosis; other malignancies. Pregnancy.
Spread of Localized Infection: Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings.
Ocular Damage: Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
Enzyme Inactivation with Intravenous Administration: Hyaluronidase recombinant should not be administered intravenously. Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.
Interaction
Co-administration of high calcium doses with thiazide diuretics may result in milk-alkali syndrome and hypercalcaemia. May potentiate digoxin toxicity. Decreases effects of calcium-channel blockers. Enhanced absorption with calcitriol (a vitamin D metabolite).
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Hyaluronidase recombinant to a solution containing another drug.
Volume of Distribution
Not available
Data regarding the volume of distribution of hyaluronidase are not readily available.
- 0.257 ± 0.073 L/kg [subjects with severe Primary IGFD] at a dose of 0.045mg/kg
Elimination Route
Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on presence of vitamin D metabolites, pH in lumen, and on dietary factors, such as calcium binding to fiber or phytates. Calcium absorption is increased when a calcium deficiency is present or when a patient is on a low-calcium diet. In patients with achlorhydria or hypochlorhydria, calcium absorption, especially with the carbonate salt, may be reduced.
Data regarding the absorption of hyaluronidase are not readily available.
While the bioavailability of rhIGF-1 after subcutaneous administration in healthy subjects has been reported to be close to 100%, the absolute bioavailability of mecasermin given subcutaneously to subjects with primary insulin-like growth factor-1 deficiency (Primary IGFD) has not been determined.
Half Life
Hyaluronidase has a half life of two minutes, but a duration of action of 24-48 hours due to its high potency.
Mean half life of 5.8 hours
Clearance
Data regarding the clearance of hyaluronidase are not readily available.
Clearance of Mecasermin is inversely proportional to IGF binding protein 3 (IGFBP-3) * Clearance is estimated to be 0.04L/hr/kg at 0.5 micrograms/mL of IGFBP-3 * Clearance is estimated to be 0.01L/hr/kg at 3 micrograms/mL of IGFBP-3 (the median level of IGFBP-3 for patients with normal IGF-1 levels)
Elimination Route
Renal (20%) - The amount excreted in the urine varies with degree of calcium absorption and whether there is excessive bone loss or failure of renal conservation. Fecal (80%) - Consists mainly of nonabsorbed calcium, with only a small amount of endogenous fecal calcium excreted.
After nonspecific proteolysis, the amino acids from protein drugs are reused for protein synthesis or further broken down and eliminated by the kidneys.
Information on the elimination of Mecasermin is not readily available, however it is likely to be metabolized by the liver and kidney like other injectable peptide drugs.
Pregnancy & Breastfeeding use
Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category C. It is also not known whether Hyaluronidase recombinant can cause fetal harm when administered to a pregnant woman. Hyaluronidase recombinant should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether hyaluronidase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hyaluronidase is administered to a nursing woman
Contraindication
Patients with calcium renal calculi or history of renal calculi. Conditions associated with hypercalcaemia and hypercalciuria.
Hyaluronidase recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in Hyaluronidase recombinant. A preliminary skin test for hypersensitivity to Hyaluronidase recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. Discontinue Hyaluronidase recombinant if sensitization occurs.
Special Warning
Pediatric Use: Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with Hyaluronidase recombinant.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Storage Condition
Store unopened in a refrigerator at 2° to 8°C. DO NOT FREEZE.
Innovators Monograph
You find simplified version here Viatrexx Derma
