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20 July 2020

FDA Approved Tepezza,Approval history of Tepezza In January 21,2020

TEPEZZA
(Teprotumumab)


·       Tepezza:
Tepezza (teprotumumab-trbw) is an entirely human monoclonal antibody and is the target inhibitor of the active thyroid eye disease (AED) insulin-like growth factor 1 (IGF- 1R) receptor.
·        FDA Approved Tepezza In January 21, 2020.
·        Tepezza Is a Brand Name Generic name of Tepezza called teprotumumab-trbw. 
·        Tepezza Is available in Injection Intravenous Dosage Form and it is Manufactured By  Horizon Therapeutics plc Company. 
·        Its Use In Treatment of Eye disease of thyroid.
·      Tepezza Is Use For:
The thyroid eye disorder (sometimes called Grave Eye Disorder) is treated with Tepezza.
Thyroid eye disorders are an infectious disease that affects tissue around the eyes of the immune system. y Symptoms are dry or watery eyes, swollen eye, bulging eyes, skin infections and eye closing problems.
For the reasons not stated in this medicament guide tepezza can be used too.
·      Before Taking Tepezza drug:
Ask the doctor if you have ever had the following:
1.     Inflammatory bowel disease;
2.     Diabetes or hyperglycemia (high blood sugar)
Tepezza can injure an unborn child. Using successful birth control to avoid abortion when you are taking Tepezza and for at least 6 months after the last dose. Ask the doctor if you get pregnant.
This might not be possible to breastfeed when taking this drug. Tell the doctor for any threats.
· How Does Given Tepezza : (Prescribing information)
Tepezza is given as an injection into a vein. The injection will be given to you by the healthcare provider.
Tepezza is usually given once every three weeks for a minimum of 8 doses.
This medication must be administered gradually, and the infusion can take 60 to 90 minutes to complete.
·       Suggested Dosage:
TEPEZZA is prescribed as a 10 mg / kg intravenous infusion with an initial dosage accompanied by a 20 mg / kg intravenous infusion for an further 7 weeks.
Recovery And Planning :
Phase 1: Measure dose(mg) for a 10 or 20 mg / kg dosage depending on the patient weight and decide the number of vials required. The teprotumumab antibody comprises 500 mg of the TEPEZZA vial.
Phase 2: Repeat any TEPEZZA 10mL sterile water vial for injection, USP, using correct aseptic technique. Ensure the diluent stream does not touch the lyophilized material, which has a cakelike appearance. Do not shake the sample, but spin the vial slowly until the lyophilized substance disappears. The recovered solution is 10.5 mL in thickness. Reconstituted solution extract 10.5 mL to receive 500 mg. The final standard is 47.6 mg / mL following reconstitution.
Phase 3: Additional 0.9 percent Sodium Chloride injection, USP, must be dissolved in the restored solution TEPEZZA. A clean syringe and needle will be used to obtain the quantity equal to the volumes of the reconstituted TEPEZZA solution to be inserted in the infusion bag and ensure a steady consistency in the infusion bag. discard the 0.9% Sodium Chloride, USP volume withdrawn.
Phase 4: Reduction of the volume of the TEPEZZA vial(s) restored by weight (kg) of a patient and move to intravenous bag of sodium chloride 0.9 percent of solution, USP for preparing a dilute solution with a minimum volume of 100 mL (under 1800 mg of dose) or 250 mL (for over 1800 mg of dose). Balance the water filtered by gentle reverse.
·        There is no preservative in the drug. For a mixture, the storage time of the reconstituted TEPEZZA solution is 4 hours at room temperatures of 20 ° C to 25 ° C (68 ° F to 77 ° F) or up to 48 hours at cold levels of 2 ° C to 8 ° C (36 ° F to 46 ° F) and the solution is in the container with a dilute comprising 0.9% sodium chloride injection. If chilled before usage, require the distilled solution to reach room temperature before infusion.
·        Parenteral medication items will, if a solution and bottle require, be checked externally for particulate matter and discolouration before administration. TEPEZZA is a colourless or slightly Gray solution that is transparent to opalescent and free from foreign particles. If some particulate matter or discolouration is detected, dump the solution.
·        The recomposed or condensed solution will not freeze.  
·      Side Effects:
When you see signs of an allergic reaction, seek emergency medical help: hives; trouble breathing; swelling of the nose, lips , tongue or throat;
Few side effects can occur after an injection, or after 1.5 hours. When you feel sticky, nervous or out of breath, or whether you have fatigue, chest pain, or rapid heartbeats, notify your caregiver.

         Call the doctor immediately in Case:
1.     Cramping stomach;
2.     Bowel loss control;
3.     A sensation of not emptying the bowels altogether;
4.     Bowel gestures, which abruptly occur;
5.     Bleeding to the rectum;
6.     Diarrhea (in blood or without blood);
7.     Blood Sugar Increased-Higher thirst, increased urination, dry mouth and a fruity scent Breath.
8.     Spasm in the muscles.
9.     Feeling fatigued or faint.
10. Taste change.
11. Dry skin.


Some Common side effects can include the following:
1.     Headache, and fatigue;
2.     Blood sugar high;
3.     Hair Loss;
4.     Diarrhoea; nausea;
5.     Dry skin;
6.     Perception of taste changed.
7.     Spasms in the muscles;
8.     Listening to problems;
WARNING: While this may be uncommon, when taking a drug, certain people can have very unpleasant and even fatal side effects. When you have any of the following signs or symptoms that could be linked to a really bad side effect, tell your doctor or get medical attention right away:
·        Allergic reactions include fever, hives, scratching and redness, bleeding, burning, blistering, or furless eyes, wheezing; stubbornness in the thorn or neck, breathing difficulty, coughing, abnormal hoarseness, or swelling of the mouth, nose , lips, tongue.
·        Signs of elevated blood sugar such as fatigue, sleepiness, nausea, vomiting more frequently, flushing, fast breath, coughing, or breath like fruit-smelling.
·        During or during the injection, injection reactions occurred. Tell your doctor immediately if your pulse, feeling heavy, shortness of breath, body discomfort or symptoms of elevated blood pressure like vomiting, dizziness, falling out, or vision shifts are involved. Notify your doctor immediately.
You May Report At 1-800-332-1088 it can submit side effects to the FDA. You may also record adverse results in https:/www.fda.gov.
·      Cost Of Tepezza :
Tepezza (Teprotumumab) Cost, the company said, cost 14,900 dollars per vial, with full treatments of approximately 23 vials over the course of six months, and the total cost of the wholesale acquisition is $343,000, with an annual net cost of 200,000 dollars.


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