Brand Information

Strength	Rate	Packing Style
mg	0.00	injection

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

NETSPOT*

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation