Macugen

DRUG DESCRIPTION

Macugen (pegaptanib sodium injection) is a sterile, aqueous solution containing pegaptanib sodium for intravitreous injection. Macugen is supplied in a single-dose, pre-filled syringe and is formulated as a 3.47 mg/mL solution, measured as the free acid form of the oligonucleotide. The active ingredient is 0.3 mg of the free acid form of the oligonucleotide without polyethylene glycol, in a nominal volume of 90 ?L. This dose is equivalent to 1.6 mg of pegaptanib sodium (pegylated oligonucleotide) or 0.32 mg when expressed as the sodium salt form of the oligonucleotide moiety. The product is a sterile, clear, preservative-free solution containing sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, hydrochloric acid, and/or sodium hydroxide to adjust the pH and water for injection.

Pegaptanib sodium is a covalent conjugate of an oligonucleotide of twenty-eight nucleotides in length that terminates in a pentylamino linker, to which two 20-kilodalton monomethoxy polyethylene glycol (PEG) units are covalently attached via the two amino groups on a lysine residue.

Pegaptanib sodium is represented by the following structural formula:

MACUGEN® (pegaptanib sodium)  Structural Formula Illustration

Where R is

and n is approximately 450.

The chemical name for pegaptanib sodium is as follows: RNA, ((2'-deoxy-2'-fluoro)C-Gm-Gm-A-A-(2'-deoxy-2'-fluoro)U-(2'-deoxy-2'-fluoro)C-Am-Gm-(2'-deoxy-2'-fluoro)U-Gm-Am-Am-(2'-deoxy-2'-fluoro)U-Gm-(2'-deoxy-2'-fluoro)C-(2'-deoxy-2'-fluoro)U-(2'-deoxy-2'fluoro)U-Am-(2'-deoxy-2'-fluoro)U-Am-(2'-deoxy-2'-fluoro)C-Am-(2'-deoxy-2'-fluoro)U-(2'deoxy-2'-fluoro)C-(2'-deoxy-2'-fluoro)C-Gm-(3'?3')-dT), 5'-ester with ?,?'-[4,12-dioxo-6[[[5-(phosphoonoxy)pentyl]amino] carbonyl]-3,13-dioxa-5,11-diaza-1,15pentadecanediyl]bis[?-methoxypoly(oxy-1,2-ethanediyl)], sodium salt.

The molecular formula for pegaptanib sodium is C294H342F13N107Na28O188P28[C2H4O]n (where n is approximately 900) and the molecular weight is approximately 50 kilodaltons.

Macugen is formulated to have an osmolality of 280-360 mOsm/Kg, and a pH of 6–7.

What are the possible side effects of pegaptanib (Macugen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • eye pain, redness, or irritation;
  • drainage or discharge from your eyes;
  • feeling that your eyes are more sensitive to light; or
  • trouble seeing, or other vision changes.

Other less serious side effects are more likely to occur, such as:

    ...

Read All Potential Side Effects and See Pictures of Macugen »


Macugen Patient Information Including Side Effects

Brand Names: Macugen

Generic Name: pegaptanib (ophthalmic injection) (Pronunciation: peg AP ta nib)

  • What is pegaptanib (Macugen)?
  • What are the possible side effects of pegaptanib (Macugen)?
  • What is the most important information I should know about pegaptanib (Macugen)?
  • What should I discuss with my health care provider before receiving pegaptanib (Macugen)?
  • How is pegaptanib used (Macugen)?
  • What happens if I miss a dose (Macugen)?
  • What happens if I overdose (Macugen)?
  • What should I avoid while receiving pegaptanib (Macugen)?
  • What other drugs will affect pegaptanib (Macugen)?
  • Where can I get more information?

What is pegaptanib (Macugen)?

Pegaptanib decreases the level of a protein that affects the cells of the eye. This protein can cause swelling and blood vessel changes that lead to macular degeneration and blindness.

Pegaptanib treats age-related macular degeneration.

Pegaptanib may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pegaptanib (Macugen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • eye pain, redness, or irritation;
  • drainage or discharge from your eyes;
  • feeling that your eyes are more sensitive to light; or
  • trouble seeing, or other vision changes.

Other less serious side effects are more likely to occur, such as:

  • cough;
  • diarrhea, nausea, vomiting, upset stomach;
  • headache, dizziness;
  • joint pain; or
  • painful or burning urination.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pegaptanib (Macugen)?

Do not use pegaptanib if you have an infection in or around your eye.

Before receiving pegaptanib, tell your doctor if you have ever had an allergic reaction when receiving a pegaptanib injection.

Pegaptanib is given as an injection through a needle placed directly into your eye. Your doctor will give you this injection in a clinic setting. Only one eye at a time will be treated unless your doctor prescribes otherwise.

Pegaptanib injections are usually given every 6 weeks.

Before your injection, you will receive a numbing medicine to make you comfortable during the injection. You will also be treated with an antibiotic medicine to prevent infection.

After your injection, your doctor will need to check your eyes periodically for up to 30 minutes. You may also need to be checked again in 2 and 7 days.

You may need to protect your eyes from bright light while you are being treated with this medication.

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