Dalteparin
Dosing in kidney impairment
Dose Reductions for Renal Insufficiency in Extended Treatment of Acute Symptomatic VTE in Adult Patients with Cancer In patients with severely impaired renal function (CrCl <30 mL/min), monitor anti-Xa levels to determine the appropriate FRAGMIN dose. Target anti-Xa range is 0.5 units/mL to 1.5 units/mL. When monitoring anti-Xa in these patients, perform sampling 4 hours to 6 hours after FRAGMIN dosing and only after the patient has received 3 to 4 doses [ see Clinical Pharmacology ] .
Preparation and administration
Administration Latex Allergy: Persons with latex allergies should not handle the FRAGMIN prefilled syringe because the needle shield may contain natural rubber latex which may cause allergic reactions. FRAGMIN is administered by subcutaneous injection. It must not be administered by intramuscular injection. FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.
Subcutaneous injection technique: Patients should be sitting or lying down and FRAGMIN administered by deep subcutaneous injection. FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection.
The entire length of the needle should be inserted at a 45 to 90 degree angle. Inspect FRAGMIN prefilled syringes and vials visually for particulate matter and discoloration prior to administration. After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Discard any unused solution after 2 weeks.
Instructions for using the prefilled single-dose syringes preassembled with needle guard devices Fixed dose syringes: To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above.
Depress the plunger of the syringe while holding the finger flange until the entire dose has been given . The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.
Graduated syringes: Hold the syringe assembly by the open sides of the device. Remove the needle shield. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner. Insert the needle into the injection area as instructed above.
Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given . The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded.
Discard the syringe assembly in approved containers. Figure
| Table 1 | ||||||
| Quantity and Volume of FRAGMIN to be Administered by Patient Weight | ||||||
| Patient weight (kg) | <50 kg | 50 kg to 59 kg | 60 kg to 69 kg | 70 kg to 79 kg | 80 kg to 89 kg | ≥90 kg |
| Quantity of FRAGMIN (units) | 5,500 units | 6,500 units | 7,500 units | 9,000 units | 10,000 units | 10,000 units |
| Volume of FRAGMIN (mL) 95,000 units / 3.8 mL | 0.22 mL | 0.26 mL | 0.3 mL | 0.36 mL | 0.4 mL | 0.4 mL |