Gallium Ga 68 dotatate - Netspot - @-(Jan 2016)- Diagnostic agent
Drug Name:Gallium Ga 68 dotatate - Netspot - @-(Jan 2016)- Diagnostic agent
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
Somatostatin Analogs: Somatostatin analogs competitively bind to the
same somatostatin receptors as Ga 68 dotatate and may affect imaging
image just prior to dosing with with long-acting somatostatin analogs
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
13. Netspot Gallium Ga 6/1/2016 A diagnostic imaging agent to detect
68 doctate rare neuroendocrine tumors Press Release Approved by FDA on 6/1/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NETSPOT safely and effectively.
See full prescribing information for NETSPOT.
NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection),
for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients
Adverse Reaction:
ADVERSE REACTIONS
The safety of Ga 68 dotatate was evaluated in three single center studies
and in a survey of the scientific literature. No serious adverse reactions
were identified
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Radiation Risk: Ga 68 dotatate contributes to a patient’s overall long-term
cumulative radiation exposure. Ensure safe handling and preparation
procedures to protect patients and health care workers from
unintentional radiation exposure
Risk for Image Misinterpretation: The uptake of Ga 68 dotatate can be seen
in a variety of tumor types other than NETs (e.g. those derived from neural
crest tissue), in other pathologic conditions, and as a normal physiologic
variant (e.g. uncinate process of the pancreas).
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients
DOSAGE AND ADMINISTRATION
• After reconstitution and radiolabeling, handle Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure (
• Instruct patients to drink a sufficient amount of water before administration, during the first hours following administration and to void frequently
• Recommended dose is 2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi) administered as intravenous bolus injection
• See the Full Prescribing Information for detailed instructions on how to prepare Ga 68 dotatate injection (e.g., reconstitution, radiolabeling)
DOSAGE FORMS AND STRENGTHS
NETSPOT is supplied as a single dose kit containing:
• Vial 1 (reaction vial with lyophilized powder) containing 40 mcg of dotatate
• Vial 2 (buffer vial) containing 1 mL of reaction buffer solution
• One accessory cartridge
Patient Information:
PATIENT COUNSELING INFORMATION
Adequate Hydration
Advise patients to drink a sufficient amount of water to ensure adequate
hydration before their PET study and urge them to drink and urinate as often
as possible during the first hours following the administration of Ga 68 dotatate
injection, in order to reduce radiation exposure.
Lactation
Advise a lactating woman to interrupt breastfeeding and pump and discard
breast milk for 12 hours after Ga 68 dotatate injection administration in order
to minimize radiation exposure to a breastfed infant..
Manufactured by:
Gipharma S.r.l.
Strada Crescentino snc-1
3040 Saluggia (Vc), Italy
Distributed by:
Advanced Accelerator Applications USA, Inc., NY 10118
Page 13
Reference ID:
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Ga 68 dotatate binds to somatostatin receptors, with highest affinity for subtype
2 receptors (sstr2). It binds to cells that express somatostatin receptors including
malignant cells, which overexpress sstr2 receptors. Gallium 68 (68Ga) is a
ß+ emitting radionuclide with an emission yield that allows positron emission
tomography (PET) imaging
2. Pharmacokinetics
Distribution
Ga 68 dotatate distributes to all sstr2-expressing organs such as pituitary, thyroid,
spleen, adrenals,kidney, pancreas, prostate, liver, and salivary glands. There is
no uptake in the cerebral cortex or in the heart, and usually thymus and lung uptakes
are low.
Elimination
A total of 12% of the injected dose is excreted in urine in the first four hours
post-injection.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
There are no studies with Ga 68 dotatate in pregnant women to inform any
drug-associated risks; however, all radiopharmaceuticals, including Ga 68
dotatate have the potential to cause fetal harm.
Animal reproduction studies have not been conducted with Ga 68 dotatate.
In the U.S general population, the estimated background risks of major birth
defects and miscarriage in clinically recognized pregnancies are 2-4%
and 15-20%, respectively.
2. Lactation
Risk Summary
There is no information on the presence of Ga 68 dotatate in human milk,
the effect on the breastfed infant, or the effect on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for Ga 68 dotatate
injection and any potential adverse effects on the breastfed child from
Ga 68 dotatate injection or from the underlying maternal condition.
Clinical Considerations
Advise a lactating woman to interrupt breastfeeding and pump and
discard breast milk for 12 hours after Ga 68 dotatate administration
in order to minimize radiation exposure to a breastfed infant.
3.Pediatric Use
The efficacy of Ga 68 dotatate PET imaging in pediatric patients with
neuroendocrine tumors is based on extrapolation from adult studies,
from studies demonstrating the ability of Ga 68 dotatate to bind to
somatostatin receptors,and from a published study of Ga 68
dotatate PET imaging in pediatric patients with somatostatin receptor
positive tumors.
The safety profile of Ga 68 dotatate is similar in adult and pediatric
patients with somatostatin receptor positive tumors. The recommended
Ga 68 dotatate injection dose in pediatric patients is weight based as in
adults
4. Geriatric Use
Clinical studies of Ga 68 dotatate injection did not include sufficient numbers
of subjects aged 65 and over, to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients.
5.OVERDOSAGE
In the event of a radiation overdose, the absorbed dose to the patient should
be reduced where possible by increasing the elimination of the radionuclide
from the body by reinforced hydration and frequent bladder voiding.
A diuretic might also be considered. If possible, an estimate of the radioactive
dose given to the patient should be perfomed
