Lupaneta Pack

Lupaneta Pack Manufacturers

• Abbvie Inc.
  

  ×

  Lupaneta Pack | Abbvie Inc.

  

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  2.1 Dosing Information

  LUPANETA PACK is a co-packaging of leuprolide acetate for depot suspension for intramuscular use and norethindrone acetate tablets for oral use. Administer as follows:

  3.75 mg of leuprolide acetate by intramuscular injection once a month for up to six injections (6 months of therapy); to be administered by a healthcare provider 5 mg of norethindrone acetate orally once daily for up to 6 months of therapy

  The initial course of treatment with leuprolide acetate for depot suspension 3.75 mg in combination with norethindrone acetate 5 mg daily is not to exceed six months.

  If the symptoms of endometriosis recur after the initial course of therapy, consider retreatment with LUPANETA PACK for up to another six months. It is recommended that bone density be assessed before retreatment begins [see Warnings and Precautions (5.1)].

  Treatment beyond two six-month courses has not been studied and is not recommended due to concerns about adverse impact on bone mineral density.

  2.2 Different Formulations of Leuprolide Acetate

  Due to the specific release characteristics of the 1-month depot formulation, HCPs should not administer 3 doses of the 3.75 mg 1-month formulation simultaneously to mimic the pharmacological profile of the 11.25 mg 3-month formulation.

  2.3 Reconstitution and Administration for Injection of Leuprolide Acetate Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. Inject the suspension immediately or discard if not used within two hours, because leuprolide acetate for depot suspension does not contain a preservative. Visually inspect the leuprolide acetate for depot suspension powder. DO NOT USE the syringe if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure 1 and Figure 2).

  Figure 1:

  Figure 2:

  Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first middle stopper is at the blue line in the middle of the barrel (see Figure 3).

  Figure 3:

  Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension (see Figure 4).

  Figure 4:

  Keep the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe. Now the syringe is ready for injection. After cleaning the injection site with an alcohol swab, administer the intramuscular injection by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or deltoid (see Figure 5). Alternate injection sites.

  Figure 5:

  NOTE: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure 6) and can be seen through the transparent LuproLoc safety device. If blood is present, remove the needle immediately. Do not inject the medication.

  Figure 6:

  Inject the entire contents of the syringe intramuscularly. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a CLICK is heard or felt (see Figure 7).

  Figure 7:

  10. Dispose of the syringe according to local regulations/procedures [see References (15)]. 2.1 Dosing Information

  LUPANETA PACK is a co-packaging of leuprolide acetate for depot suspension for intramuscular use and norethindrone acetate tablets for oral use. Administer as follows:

  3.75 mg of leuprolide acetate by intramuscular injection once a month for up to six injections (6 months of therapy); to be administered by a healthcare provider 5 mg of norethindrone acetate orally once daily for up to 6 months of therapy

  The initial course of treatment with leuprolide acetate for depot suspension 3.75 mg in combination with norethindrone acetate 5 mg daily is not to exceed six months.

  If the symptoms of endometriosis recur after the initial course of therapy, consider retreatment with LUPANETA PACK for up to another six months. It is recommended that bone density be assessed before retreatment begins [see Warnings and Precautions (5.1)].

  Treatment beyond two six-month courses has not been studied and is not recommended due to concerns about adverse impact on bone mineral density.

  2.2 Different Formulations of Leuprolide Acetate

  Due to the specific release characteristics of the 1-month depot formulation, HCPs should not administer 3 doses of the 3.75 mg 1-month formulation simultaneously to mimic the pharmacological profile of the 11.25 mg 3-month formulation.

  2.3 Reconstitution and Administration for Injection of Leuprolide Acetate Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. Inject the suspension immediately or discard if not used within two hours, because leuprolide acetate for depot suspension does not contain a preservative. Visually inspect the leuprolide acetate for depot suspension powder. DO NOT USE the syringe if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure 1 and Figure 2).

  Figure 1:

  Figure 2:

  Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first middle stopper is at the blue line in the middle of the barrel (see Figure 3).

  Figure 3:

  Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension (see Figure 4).

  Figure 4:

  Keep the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe. Now the syringe is ready for injection. After cleaning the injection site with an alcohol swab, administer the intramuscular injection by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or deltoid (see Figure 5). Alternate injection sites.

  Figure 5:

  NOTE: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure 6) and can be seen through the transparent LuproLoc safety device. If blood is present, remove the needle immediately. Do not inject the medication.

  Figure 6:

  Inject the entire contents of the syringe intramuscularly. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a CLICK is heard or felt (see Figure 7).

  Figure 7:

  10. Dispose of the syringe according to local regulations/procedures [see References (15)].

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• Abbvie Inc.
  

  ×

  Lupaneta Pack | Abbvie Inc.

  

  ---

  2.1 Dosing Information

  LUPANETA PACK is a co-packaging of leuprolide acetate for depot suspension for intramuscular use and norethindrone acetate tablets for oral use. Administer as follows:

  11.25 mg of leuprolide acetate by intramuscular injection once every three months for up to two injections (6 months of therapy); to be administered by a healthcare provider 5 mg of norethindrone acetate orally once daily for up to 6 months of therapy

  The initial course of treatment with leuprolide acetate for depot suspension 11.25 mg in combination with norethindrone acetate 5 mg daily is not to exceed six months.

  If the symptoms of endometriosis recur after the initial course of therapy, consider retreatment with LUPANETA PACK for up to another six months. It is recommended that bone density be assessed before retreatment begins [see Warnings and Precautions (5.1)].

  Treatment beyond two six-month courses has not been studied and is not recommended due to concerns about adverse impact on bone mineral density.

  2.2 Different Formulations of Leuprolide Acetate

  Due to different release characteristics, a fractional dose of the leuprolide acetate for depot suspension 3-month depot formulation is not equivalent to the same dose of the monthly formulation and should not be given.

  2.3 Reconstitution and Administration for Injection of Leuprolide Acetate Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. Inject the suspension immediately or discard if not used within two hours, because leuprolide acetate for depot suspension does not contain a preservative. Visually inspect the leuprolide acetate for depot suspension powder. DO NOT USE the syringe if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure 1 and Figure 2).

  Figure 1:

  Figure 2:

  Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first middle stopper is at the blue line in the middle of the barrel (see Figure 3).

  Figure 3:

  Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension (see Figure 4).

  Figure 4:

  Keep the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe. Now the syringe is ready for injection. After cleaning the injection site with an alcohol swab, administer the intramuscular injection by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or deltoid (see Figure 5).

  Figure 5:

  NOTE: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure 6) and can be seen through the transparent LuproLoc safety device. If blood is present, remove the needle immediately. Do not inject the medication.

  Figure 6:

  Inject the entire contents of the syringe intramuscularly. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a CLICK is heard or felt (see Figure 7).

  Figure 7:

  Dispose of the syringe according to local regulations/procedures [see References (15)]. 2.1 Dosing Information

  LUPANETA PACK is a co-packaging of leuprolide acetate for depot suspension for intramuscular use and norethindrone acetate tablets for oral use. Administer as follows:

  11.25 mg of leuprolide acetate by intramuscular injection once every three months for up to two injections (6 months of therapy); to be administered by a healthcare provider 5 mg of norethindrone acetate orally once daily for up to 6 months of therapy

  The initial course of treatment with leuprolide acetate for depot suspension 11.25 mg in combination with norethindrone acetate 5 mg daily is not to exceed six months.

  If the symptoms of endometriosis recur after the initial course of therapy, consider retreatment with LUPANETA PACK for up to another six months. It is recommended that bone density be assessed before retreatment begins [see Warnings and Precautions (5.1)].

  Treatment beyond two six-month courses has not been studied and is not recommended due to concerns about adverse impact on bone mineral density.

  2.3 Reconstitution and Administration for Injection of Leuprolide Acetate Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. Inject the suspension immediately or discard if not used within two hours, because leuprolide acetate for depot suspension does not contain a preservative. Visually inspect the leuprolide acetate for depot suspension powder. DO NOT USE the syringe if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure 1 and Figure 2).

  Figure 1:

  Figure 2:

  Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first middle stopper is at the blue line in the middle of the barrel (see Figure 3).

  Figure 3:

  Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension (see Figure 4).

  Figure 4:

  Keep the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe. Now the syringe is ready for injection. After cleaning the injection site with an alcohol swab, administer the intramuscular injection by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or deltoid (see Figure 5).

  Figure 5:

  NOTE: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure 6) and can be seen through the transparent LuproLoc safety device. If blood is present, remove the needle immediately. Do not inject the medication.

  Figure 6:

  Inject the entire contents of the syringe intramuscularly. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a CLICK is heard or felt (see Figure 7).

  Figure 7:

  Dispose of the syringe according to local regulations/procedures [see References (15)].

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