IGF-1 & LR3 IGF-1 Handling, Storage and Administration Directions For: • Before Taking This Medication • Storage • Your Physician’s Recommended Dosing • Dilution/Reconstitution • Subcutaneous Injection Preparation and Administration BEFORE TAKING THIS MEDICATION
STORAGE
Take only according to your physician’s instructions. If you have any questions about administration, contact your physician or the pharmacy.
Your medication is shipped on dry ice to ensure potency. Upon receipt, store it immediately in a standard home refrigerator at 2°C to 8°C (35°F to 46°F) before and after opening.
Take this medication with meals. Patients can experience reductions in blood sugar (hypoglycemia) if taken on an empty stomach, especially first thing in the morning. This medication should not be administered when a meal or snack has been omitted from your daily schedule. When taking this medication, always have a source of sugar such as orange juice, glucose gel, candy or milk available in case symptoms of hypoglycemia occur.
Before opening, vials are stable for up to six months, and after reconstituting, vials are stable for 28 days at these temperatures. Do not freeze after reconstitution.
This medication should not be taken in the presence of active or suspected malignancy or cancer, and therapy should be discontinued if evidence of malignancy or cancer develops.
If your physician has prescribed...
Do not take this medication if you are pregnant, planning to become pregnant or are breastfeeding. Patients should avoid engaging in any high-risk activities (e.g., driving, operating heavy machinery, etc.) within 2 to 3 hours after dosing, particularly during the initiation of treatment, until tolerability and a stable dose have been established.
DOSING Your dosing volume Your dose is approximately...
20 mcg
13 units of medication
50 mcg
33 units of medication
DILUTION/RECONSTITUTION Remove the caps from the vial of powdered medication and the bacteriostatic water included in your medication kit. Dispose of the caps.
The dose of this medication should never be increased to make up for one or more missed doses.
Using the included 3cc syringe, dilute each 3ml vial of medication with 2cc of the bacteriostatic water.
Should you notice any adverse side effects, report them to your physician immediately and to
[email protected] immediately.
To do this, draw 2cc of bacteriostatic water to the 2cc marker on the syringe. Inject it into the vial of the powdered medication.
Compounded IGF-1 and LR3 IGF-1 have not been approved by the FDA to treat or diagnose any disease and have not been determined by the FDA to be safe or effective for any use. © 2014 Vicrin Inc. All rights reserved.
Do not shake the vial; gently swirl the contents. When properly mixed, the solution should be clear.
10. Make sure that the tip of the needle is completely covered by the medication.
When finished, the remaining reconstituted medication should be stored in the refrigerator per the storage instructions above.
11. Pull back on the plunger to fill the syringe with the correct dose of medication
Dispose of the remaining bacteriostatic water and the 3cc drawing syringe. See safe needle disposal instructions at the end of this document.
12. Keep the vial upside down, with the needle in the vial pointed upward. Tap the syringe, or “flick” it with your fingertips to remove bubbles.
SUBCUTANEOUS INJECTION PREPARATION AND ADMINISTRATION
13. Once the bubbles are at the top of the syringe, gently push on the plunger to force the bubbles out of the syringe and back into the vial. Note: It is important to eliminate large air bubbles because they take up space needed for the medication, and they may cause pain or discomfort when injected.
What is a subcutaneous injection? A subcutaneous injection is given in the fatty layer of tissue just under the skin. These injections are given subcutaneously because there is little blood flow to fatty tissue, and the injected medication is generally absorbed more slowly, sometimes over 24 hours. Wash your hands prior to administration thoroughly to minimize the opportunity for infection.
Drawing reconstituted medication into the syringe 1. Check the label for correct medication. 2. Clean the exposed rubber stopper using an alcohol swab. 3. Remove the syringe from the plastic or paper packaging. 4. Pull back and forth on the plunger by grasping the plunger handle. 5. With the needle capped, pull back the plunger, filling the syringe with air equal to the amount of medication to be administered.
14. After removing the bubbles, check the dose of medication in the syringe to be sure you have drawn the correct amount. 15. After the medication is correctly drawn, carefully replace the needle cap to prevent contamination.
Locating injection sites Subcutaneous injections can be given in the arms, legs, or abdomen. Ask your nurse or doctor to help you select the best sites to administer your medication. Do not give subcutaneous injections in areas where the skin is burned, hardened, inflamed, swollen, or damaged by a prior injection. Arms The area between your shoulder and elbow is where injections are given. Thigh
6. Remove the cap covering the needle and set it on its side to prevent contamination. Be careful not to touch the needle.
The area between the top of your knee and below your hip on the outer side of your leg is where injections may be given.
7. With the vial in an upright position, push the needle through the cleansed rubber stopper on the vial. Push the needle straight down into the vial, being careful not to bend the needle.
The area below the lower ribs as far around as you can pinch up fatty tissue using a 1-inch area around the navel.
8. Inject the air in the syringe into the vial. 9. Turn the vial upside down, with the needle remaining in the vial. The needle will be pointing upward.
Abdomen
Note: It is extremely important to rotate injection sites to keep the skin healthy. Repeated injections in the same spot can cause scarring and hardening of fatty tissue that will interfere with absorption of medication. Each injection should be about 1 inch apart. Avoid giving injections in areas that are burned, reddened, inflamed, swollen or damaged by prior injections.
Compounded IGF-1 and LR3 IGF-1 have not been approved by the FDA to treat or diagnose any disease and have not been determined by the FDA to be safe or effective for any use. © 2014 Vicrin Inc. All rights reserved.
Giving the injection
Safe Needle Disposal
Note: It is important to cleanse the skin using an alcohol swab. Allow the alcohol to dry completely by air.
It is extremely important to safely dispose of needles. Place the syringe or needle in a hard plastic or metal container with a tightly secured lid. Do not recap needles after use. Keep the container out of the reach of children or pets. When the container is three quarters full, take it to a health care facility for proper disposal.
1. Take the cap off of the needle. Be careful not to contaminate the needle. Place the cap on its side. 2. Hold the syringe in one hand like pencil or a dart. 3. Grasp the skin between the thumb and index finger with your other hand and pinch up. 4. Quickly thrust the needle all the way into the skin. Do not “push” the needle into the skin slowly or thrust the needle into the skin with great force. Do not press down on the top of the plunger while piercing the skin. 5. Insert the needle at a 90 degree angle to the surface of the skin to ensure that the medication will be injected into the fatty tissue. 6. After the needle is completely inserted into the skin, release the skin that you are grasping. Press down on the plunger to release medication into the subcutaneous layer in a slow, steady pace. 7. As the needle is pulled out of the skin, gently press gauze onto the needle insertion site. Pressure over the site while removing the needle prevents skin from pulling back, which may be uncomfortable.
Compounded IGF-1 and LR3 IGF-1 have not been approved by the FDA to treat or diagnose any disease and have not been determined by the FDA to be safe or effective for any use. © 2014 Vicrin Inc. All rights reserved.
Recombinant Human IGF-1 (1-70) Derived from E. coli Technical Specifications Recombinant Human Insulin-like Growth Factor 1 (IGF-1) is produced with our E. coli expression system. The target protein is expressed with sequence (G49-A118) of Human IGF-1. Description Accession #: P05019 Synonyms: Insulin-Like Growth Factor 1, IGF-1, Mechano Growth Factor, MGF, Somatomedin-C, IGF-1,IBP-1
Formulation Lyophilized from a 0.2 μM filtered solution of 20mM acetic acid, 4% Mannitol,pH 4.5 The product is shipped at storage temperature.
Shipping Upon receipt, store it immediately at the temperature listed below. Reconstituted protein should be stored in a standard home refrigerator at 2°C to 8°C (35°F to 46°F) before Storage and after opening. Before opening, vials are stable for up to six months, and after opening, vials are stable for 28 days at these temperatures. All storage temperatures consistent with standard residential frost-free refrigerators/freezers.
Always centrifuge tubes before opening. Do not mix by vortex pipetting. It is not recommended to reconstitute to a concentration of less than 100μg/ml. Dissolve the lyophilized protein Reconstitution in 1X PBS. Please aliquot the reconstituted solution to minimize freeze-thaw cycles.
Quality Control
Bioactivity*: The ED50 for this effect is typically 0.2-1.0 ng/ml. Corresponding to a specific activity of ≥ 1.0× 10^6 unit/mg. *Measured in a serum-free cell proliferation assay using MCF-7 human breast cancer cells.
Purity: Greater than 95% as determined by reducing SDS-PAGE. Endotoxin: Less than 0.1 ng/µg (1 IEU/µg).
Amino Acid GPETLCGAELVDALQFVCGDRGFYFNKPTGYGSSSRRAPQTGIVDECCFRSCDLRRLEMYCAPLKPAKSA Sequence Insulin-like growth factor 1 (IGF-1) belongs to the family of insulin-like growth factors that are structurally homologous to proinsulin. Mature IGFs are generated by proteolytic processing of inactive precursor protein containing N-terminal and C-terminal propeptide regions. Mature human IGF-I consisting of 70 amino acids with Background 94% identity with mouse IGF-1 and exhibits cross-species activity. IGF-1 binds IGF-1R, IGF-2R, and the insulin receptor and plays a key role in cell cycle progression, cell proliferation and tumor progression. IGF-1 expression is regulated by growth hormone.
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INSIST ON QUALITY ® INSIST ON VICRIN
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Amino Acid Analogs
Before you begin any course of injectable medication, you want to be certain that the product you’re using meets essential standards for quality, purity and more.
Trust Only Vicrin –Approved Pharmacies for Quality, Purity and Consistency in Every Dose ®
What does it mean when your medication carries the Vicrin® name and logo? It means that your medication has been prepared by independent pharmacies that have been authorized by Vicrin® to compound IGF-1 and LR3 IGF-1 for prescription by licensed physicians. Other providers offer these products “for research purposes only” - making it illegal for physicians to prescribe them and illegal for patients to purchase them.
That’s the reason you make sure your medication carries the Vicrin® logo.
You’re not a research subject. You’re a patient. That’s why the medication we provide has been analyzed and tested to ensure that you receive a pure, consistent and bioactive product. In fact, our protocol includes the following procedures and assurances: •
The source medication is tested for dose-response bioactivity through cell culture by a leading United States-based endocrinological research laboratory
•
This process is performed on MVT1 cells, examining the product on p-IGF-1 receptors and analyzing for p-Akt response, ensuring appropriate bioactivity
•
The compounding pharmacy performs sterility, potency and pH testing on all injectable preparations, including potency verification of finished compounds through highly calibrated scientific instrumentation
•
Compounds are certified through the use of state-ofthe-art technology, including a high performance liquid chromatograph, a UV spectrophotometer gas chromatograph and an infrared spectrophotometer
•
These testing procedures follow United States Pharmacopeia USP 85 guidelines for endotoxins
•
Master formulas and lot-specific worksheets for all compounds ensure that individual prescriptions can be traced back to the original formula log sheet and source of ingredients
•
The pharmacy maintains appropriate hygiene in the production of all sterile injectables, including the use of Class 100 laminar airflow hoods inside a Class 1000 clean room that achieves 0.2 micron filtration
•
The compounding lab facility performs post-filtration filterintegrity testing, semi-annual independent certifications of clean rooms and monthly independent lab tests of air and surface samples in clean rooms
Each of these is an essential element of a complete program that makes your safety and satisfaction its top priority. Accept only Vicrin®-authorized products to be assured that the medications you receive are up to the exacting standards that you and your health care provider demand. Compounded IGF-1 and LR3 IGF-1 have not been approved by the FDA to treat or diagnose any disease and have not been determined by the FDA to be safe or effective for any use.
www.Vicrin.com
855-4-VICRIN
FAX: 855-LR3-IGF1
© 2014 Vicrin Inc. All rights reserved. Rev: cred2414
