OctreoScan

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• Your doctor may tell you to use a laxative like bisacodyl or lactulose before and after getting OctreoScan. Follow what your doctor has told you.
• You will need to empty your bladder often after the test is over as your doctor has told you. Talk with your doctor.
• Drink lots of noncaffeine liquids before the test as your doctor has told you.
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Very bad headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Pain where the shot was given.
• Loose stools (diarrhea).
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Before administration, a patient should be well hydrated. After administration, the patient must be encouraged to drink fluids liberally. Elimination of extra fluid intake will help reduce the radiation dose by flushing out unbound, labelled pentetreotide by glomerular filtration. It is also recommended that a mild laxative (e.g., bisacodyl or lactulose) be given to the patient starting the evening before the radioactive drug is administered, and continuing for 48 hours. Ample fluid uptake is necessary during this period as a support both to renal elimination and the bowel-cleansing process. In a patient with an insulinoma, bowel-cleansing should be undertaken only after consultation with an endocrinologist.

The recommended intravenous dose for planar imaging is 111 MBq (3.0 mCi) of indium In-111 pentetreotide prepared from an OctreoScan kit. The recommended intravenous dose for SPECT imaging is 222 MBq (6.0 mCi) of indium In-111 pentetreotide.

The dose should be confirmed by a suitably calibrated radioactivity ionization chamber immediately before administration.

As with all intravenously administered products, OctreoScan should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.

Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves should be worn during the administration procedure.

Do not administer OctreoScan in TPN solutions or through the same intravenous line.

The OctreoScan kit (NDC 69945-050-40) is supplied with the following components:

1. A 10-mL OctreoScan Reaction Vial which contains a lyophilized mixture of:

   (i) 10 μg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA),
   (ii) 2.0 mg gentisic acid [2, 5-dihydroxybenzoic acid],
   (iii) 4.9 mg trisodium citrate, anhydrous,
   (iv) 0.37 mg citric acid, anhydrous, and
   (v) 10.0 mg inositol.

   Before lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.

2. A 10-mL vial of Indium In-111 Chloride Sterile Solution, which contains 1.1 mL or 111 MBq/mL (3.0 mCi/mL) indium In-111 chloride in 0.02 N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 μg/mL (ferric ion, 1.2 μg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.

In addition, the kit also contains the following items: (1) a 25 G x 5/8” needle (B-D, Monoject) used to transfer Indium In-111 Chloride Sterile Solution to the OctreoScan Reaction Vial, (2) pressure sensitive label, and (3) a package insert.

Note: Read complete directions thoroughly before starting preparation.

Procedure Precautions and Notes

1. All transfers and penetrations of the vial stoppers by a needle must use aseptic technique.
2. Wear waterproof gloves during the entire procedure and while withdrawing the patient-dose from the OctreoScan Reaction Vial.
3. Transfer Indium In-111 Chloride Sterile Solution with an adequately shielded, sterile syringe using the transfer needle in the kit.
4. Adequate shielding should be maintained at all times until the preparation is administered to the patient, disposed of in an approved manner, or allowed to decay to safe levels of radioactivity. A shielded, sterile syringe should be used for withdrawing and injecting the preparation.
5. Do not inject into TPN administration bags or their intravenous lines.

Procedure for the Preparation of Indium In-111 Pentetreotide

1. Place the OctreoScan Reaction Vial in a lead dispensing shield (of minimum wall thickness 1/4 inch) fitted with a lid.
2. Swab the rubber stopper of the reaction vial with an appropriate antiseptic and allow the vial to dry.
3. Aseptically remove the contents of the Indium In-111 Chloride Sterile Solution vial using the needle provided and a shielded, sterile syringe.
4. Inject the Indium In-111 Chloride Sterile Solution into the OctreoScan Reaction Vial.
5. Gently swirl the OctreoScan Reaction Vial until the lyophilized pellet is completely dissolved.
6. Incubate the indium In-111 pentetreotide solution at or below 25°C (77°F) for a minimum of 30 minutes. Note: A 30 minute incubation time is required. Shorter incubation periods may result in inadequate labeling.
7. Using proper shielding, visually inspect the vial contents. The solution should be clear, colorless, and free of particulate matter. If not, the solution should not be used. It should be disposed in a safe and approved manner.
8. Assay the indium In-111 pentetreotide solution using a suitably calibrated ionization chamber. Record the date, time, total activity, and patient identifier (e.g., patient name and number) on the radioassay information label and affix the label to the lead dispensing shield.
9. The labeling yield of the reconstituted solution should be checked before administration to the patient, according to the instructions given below. If the radiochemical purity is less than 90%, the product should not be used.
10. Store the reaction vial containing the indium In-111 pentetreotide solution at or below 25°C (77°F) until use. The indium In-111 pentetreotide must be used within six hours of preparation.
11. If desired, the preparation can be diluted to a maximum volume of 3 mL with 0.9% Sodium Chloride Injection, U.S.P. immediately prior to injection. The sample should be drawn up into a shielded, sterile syringe and administered to the patient.

Indium In 111 Chloride
Sterile Solution

Sterile, non-pyrogenic solution, contains no bacteriostatic preservation.

NOT FOR DIRECT ADMINISTRATION

For intravenous use after drug preparation. See package insert for directions for use.

Vial contains 1.1 mL of 111 MBq/mL (3.0mCi/mL) aqueous indium In 111 chloride and 3.5 µg/mL ferric chloride (1.2 µg/mL ferric ion) in 0.02N hydrochloric acid.

Store at or below 25°C (77°F).

Rx only

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.

Manufactured by:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043

Made in USA

Mallinckrodt™
Pharmaceuticals

CAUTION RADIOACTIVE MATERIAL

A117C0
R10/2015