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:
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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